FDA product code · General, Plastic Surgery
GDWStaple, Implantable
Product code GDW covers Staple, Implantable, a Class II device regulated under 21 CFR 878.4750. FDA has cleared 283 devices in this code, 3 of them in the last 12 months. Median review time across the 283 most recent decisions is 71 days. openFDA lists 225 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 878.4750
- Review panel
- General, Plastic Surgery
- Clearances
- 283
What is happening in GDW right now?
GDW (Staple, Implantable) has three findings, most consequential first. 3 recalls opened in the last 12 months and not yet terminated (Class II) (Z-0485-2026, Z-0486-2026, Z-0147-2026). 1 first-time filer in the last 12 months, Covidien (Part of Medtronic) (K253657). The code is crowded, scoring 69 of 100 — 93 companies hold a clearance here and 3 arrived in the last 12 months (GDW:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-0485-2026, Z-0486-2026, Z-0147-2026 |
| New entrant | Worth knowing | K253657 |
| Crowding | Context | GDW:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in GDW?
FDA has cleared 283 devices under product code GDW since the 510(k) programme began in 1976, 3 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260196 | ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON Circular Stapler (CDH29mm); ETHICON Circular Stapler (CDH33mm); ETHICON Circular Stapler - XL Sealed (ECS21mm); ETHICON Circular Stapler - XL Sealed (ECS25mm); ETHICON Circular Stapler - XL Sealed (ECS29mm); ETHICON Circular Stapler - XL Sealed (ECS33mm) | Ethicon Endo-Surgery, LLC | |
| K253657 | Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads | Covidien (Part of Medtronic) | |
| K252739 | ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler (EC3DT45S); ETHICON 4000 45mm Long Stapler (EC3DT45L); ETHICON 3D 45mm White Reload (ER45W); ETHICON 3D 45mm Blue Reload (ER45B); ETHICON 3D 45mm Green Reload (ER45G); ETHICON 3D 45mm Black Reload (ER45T) | Ethicon Endo-Surgery, LLC | |
| K250835 | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T) | Ethicon Endo-Surgery, LLC | |
| K243276 | ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler (GTX60); ECHELON LINEAR Stapler 90mm Stapler (GTX90); ECHELON LINEAR Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR Stapler 3D 90mm Green Reload (GTXR90G) | Ethicon Endo-Surgery, LLC | |
| K241630 | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T) | Ethicon Endo-Surgery, LLC | |
| K242679 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series) | Fengh Medical Co., Ltd. | |
| K222487 | Anika Tissue Tack Fixation System | Anika Therapeutics, Inc. | |
| K222210 | AEON Endoscopic Stapler | Lexington Medical, Inc. | |
| K223760 | ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR 100 mm Cutter (GLC100);ECHELON LINEAR Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR Cutters 100mm Green Reload (GLCR100G) | Ethicon Endo-Surgery |
How long does FDA review take for GDW?
The median FDA review time for GDW is 71 days, measured across the 283 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in GDW?
openFDA lists 225 recall records against product code GDW. A recall record covers one firm's corrective action and may span many device lots.
Z-0485-2026Open, ClassifiedCovidien
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
Z-0486-2026Open, ClassifiedCovidien
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
Z-0147-2026Open, ClassifiedEthicon Endo Surgery, LLC
The devices were shipped unsterilized.
Z-1746-2025Open, ClassifiedEthicon Endo Surgery, LLC
Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death.
Z-3096-2024Open, ClassifiedSmith & Nephew, Inc.
Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
Showing the 5 most recently initiated of 225. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for GDW?
MAUDE holds 38,913 adverse-event reports naming product code GDW, 7,515 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in GDW unusual?
Every month with enough history behind it falls inside GDW's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1,021 | Insufficient history | No expected range — too little history | |
| 1,012 | Insufficient history | No expected range — too little history | |
| 1,416 | Insufficient history | No expected range — too little history | |
| 1,120 | Insufficient history | No expected range — too little history | |
| 1,227 | Insufficient history | No expected range — too little history | |
| 1,471 | Insufficient history | No expected range — too little history | |
| 1,152 | Insufficient history | No expected range — too little history | |
| 1,079 | Insufficient history | No expected range — too little history | |
| 1,100 | Insufficient history | No expected range — too little history | |
| 1,335 | Insufficient history | No expected range — too little history | |
| 1,128 | Insufficient history | No expected range — too little history | |
| 951 | Insufficient history | No expected range — too little history | |
| 1,149 | Insufficient history | No expected range — too little history | |
| 1,059 | Insufficient history | No expected range — too little history | |
| 1,126 | Insufficient history | No expected range — too little history | |
| 1,149 | Insufficient history | No expected range — too little history | |
| 1,086 | Insufficient history | No expected range — too little history | |
| 1,250 | Insufficient history | No expected range — too little history | |
| 1,109 | Insufficient history | No expected range — too little history | |
| 1,000 | Insufficient history | No expected range — too little history | |
| 938 | Insufficient history | No expected range — too little history | |
| 1,011 | 691–1,228 | Within expected (691–1,228) | |
| 782 | 655–1,039 | Within expected (655–1,039) | |
| 828 | 706–1,142 | Within expected (706–1,142) | |
| 993 | 685–1,171 | Within expected (685–1,171) | |
| 972 | 684–1,088 | Within expected (684–1,088) | |
| 956 | 737–1,159 | Within expected (737–1,159) | |
| 1,301 | 1,223–1,758 | Within expected (1,223–1,758) | |
| 886 | 868–1,298 | Within expected (868–1,298) | |
| 978 | 817–1,344 | Within expected (817–1,344) | |
| 1,030 | 827–1,253 | Within expected (827–1,253) | |
| 835 | 742–1,126 | Within expected (742–1,126) | |
| 1,063 | 769–1,232 | Within expected (769–1,232) | |
| 962 | 915–1,444 | Within expected (915–1,444) | |
| 983 | 700–1,182 | Within expected (700–1,182) | |
| 1,020 | 781–1,307 | Within expected (781–1,307) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in GDW.
Who has entered GDW in the last year?
One company filed in GDW for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Covidien (Part of Medtronic) | K253657 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in GDW?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in GDW?
Across the 283 most recent decisions, these applicants filed most often in GDW.
| Applicant | Recent clearances |
|---|---|
| United States Surgical, A Division of Tyco Healthc | 28 |
| Ethicon Endo-Surgery, LLC | 27 |
| Covidien | 22 |
| Power Medical Interventions, Inc. | 22 |
| Ethicon Endo-Surgery, Inc. | 16 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in GDW file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Ethicon Endo Surgery, LLC | 44 | 3 |
| Covidien | 27 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch GDW
Get an email the morning anything changes in GDW — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.