FDA product code · Gastroenterology, Urology
GCJLaparoscope, General & Plastic Surgery
Product code GCJ covers Laparoscope, General & Plastic Surgery, a Class II device regulated under 21 CFR 876.1500. FDA has cleared 1,426 devices in this code, 30 of them in the last 12 months. Median review time across the 1,426 most recent decisions is 88 days. openFDA lists 274 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 876.1500
- Review panel
- Gastroenterology, Urology
- Clearances
- 1,426
What is happening in GCJ right now?
GCJ (Laparoscope, General & Plastic Surgery) has seven findings, most consequential first. K261614 cites a recalled device one generation upstream — K220069, recall Z-2761-2026 (Class II, Open, Classified). K253541 cites a recalled device 2 generations upstream — K220069, recall Z-2761-2026 (Class II, Open, Classified). 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2761-2026, Z-1010-2026, Z-0309-2026, Z-0310-2026, Z-0311-2026). Adverse events reported in 2026-03 ran high — 770 reports against an expected 458 to 731 (GCJ:MAUDE:2026-03). 16 first-time filers in the last 12 months, including Medical Impact and FloShield, Inc (K253541, K260710, K260414, K260318, K260183). Clearances are running 32% slower — a median 116 days over the last 12 months against 88 days all-time (elapsed calendar days, not FDA review days) (GCJ:review_time:12m). The code is crowded, scoring 100 of 100 — 511 companies hold a clearance here and 30 arrived in the last 12 months (GCJ:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Predicate risk | Class II recall | K261614, K220069, Z-2761-2026 |
| Predicate risk | Class II recall | K253541, K220069, Z-2761-2026 |
| Recall | Class II recall | Z-2761-2026, Z-1010-2026, Z-0309-2026, Z-0310-2026, Z-0311-2026 |
| Adverse-event spike | Serious | GCJ:MAUDE:2026-03 |
| New entrant | Worth knowing | K253541, K260710, K260414, K260318, K260183 |
| Review time | Context | GCJ:review_time:12m |
| Crowding | Context | GCJ: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.
What does product code GCJ cover?
GCJ is FDA's product code for Laparoscope, General & Plastic Surgery, a Class II device regulated under 21 CFR 876.1500.
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Source: openFDA device/classification · record GCJ · retrieved
How many devices has FDA cleared in GCJ?
FDA has cleared 1,426 devices under product code GCJ since the 510(k) programme began in 1976, 30 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253541 | EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device) | Medical Impact | |
| K261614 | LED LCD Monitor (OEV-271H) | Lg Electronics.Inc | |
| K261249 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | |
| K260710 | FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air) | FloShield, Inc. | |
| K260414 | Tech-Image Video Endoscope System | Tech-Image CO., LTD. | |
| K253994 | TroKit Laparoscope Lens Wiper | TroCare, LLC | |
| K252532 | Inno-Port Disposable Bladed Trocar | Taiwan Surgical Corporation | |
| K260318 | 4K NIR/ICG Imaging System | Zhejiang Healnoc Technology Co., Ltd. | |
| K260183 | MediBot Needle Driver Uno | Parallel Robotics, LLC | |
| K252985 | Laport | Sejong Medical Co., Ltd. |
How long does FDA review take for GCJ?
The median FDA review time for GCJ is 88 days, measured across the 1,426 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 GCJ?
openFDA lists 274 recall records against product code GCJ. A recall record covers one firm's corrective action and may span many device lots.
Z-2761-2026Open, ClassifiedOlympus Corporation of the Americas
Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
Z-1010-2026Open, ClassifiedApplied Medical Resources Corp
There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
Z-0309-2026Open, ClassifiedAesculap, Inc.
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Z-0310-2026Open, ClassifiedAesculap, Inc.
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Z-0311-2026Open, ClassifiedAesculap, Inc.
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Showing the 5 most recently initiated of 274. 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 GCJ?
MAUDE holds 18,007 adverse-event reports naming product code GCJ, 4,416 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 GCJ unusual?
One month sits above GCJ's own expected range: 1 March 2026.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 353 | Insufficient history | No expected range — too little history | |
| 370 | Insufficient history | No expected range — too little history | |
| 398 | Insufficient history | No expected range — too little history | |
| 423 | Insufficient history | No expected range — too little history | |
| 544 | Insufficient history | No expected range — too little history | |
| 576 | Insufficient history | No expected range — too little history | |
| 430 | Insufficient history | No expected range — too little history | |
| 511 | Insufficient history | No expected range — too little history | |
| 467 | Insufficient history | No expected range — too little history | |
| 518 | Insufficient history | No expected range — too little history | |
| 613 | Insufficient history | No expected range — too little history | |
| 594 | Insufficient history | No expected range — too little history | |
| 581 | Insufficient history | No expected range — too little history | |
| 537 | Insufficient history | No expected range — too little history | |
| 519 | Insufficient history | No expected range — too little history | |
| 488 | Insufficient history | No expected range — too little history | |
| 492 | Insufficient history | No expected range — too little history | |
| 466 | Insufficient history | No expected range — too little history | |
| 508 | Insufficient history | No expected range — too little history | |
| 363 | Insufficient history | No expected range — too little history | |
| 368 | Insufficient history | No expected range — too little history | |
| 331 | 204–587 | Within expected (204–587) | |
| 335 | 147–511 | Within expected (147–511) | |
| 414 | 181–559 | Within expected (181–559) | |
| 511 | 227–564 | Within expected (227–564) | |
| 489 | 268–537 | Within expected (268–537) | |
| 495 | 302–587 | Within expected (302–587) | |
| 566 | 513–928 | Within expected (513–928) | |
| 508 | 349–670 | Within expected (349–670) | |
| 473 | 367–705 | Within expected (367–705) | |
| 543 | 345–683 | Within expected (345–683) | |
| 481 | 316–622 | Within expected (316–622) | |
| 603 | 365–683 | Within expected (365–683) | |
| 560 | 460–804 | Within expected (460–804) | |
| 599 | 391–643 | Within expected (391–643) | |
| 770 | 458–731 | Above expected (458–731) |
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 GCJ.
Who has entered GCJ in the last year?
8 companies filed in GCJ for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Medical Impact | K253541 | |
| FloShield, Inc. | K260710 | |
| Tech-Image CO., LTD. | K260414 | |
| Zhejiang Healnoc Technology Co., Ltd. | K260318 | |
| Parallel Robotics, LLC | K260183 | |
| Kms Medical Technology Co., Ltd. | K252858 | |
| Scopix , Ltd. | K260089 | |
| Suzhou Shenyun Medical Equipment Co., Ltd. | K260197 |
"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 GCJ?
These devices in GCJ cite an earlier clearance as their predicate.
- K253541 cites K261614
- K261614 cites K220069
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 GCJ?
Across the 1,426 most recent decisions, these applicants filed most often in GCJ.
| Applicant | Recent clearances |
|---|---|
| KARL STORZ Endoscopy-America, Inc. | 47 |
| Origin Medsystems, Inc. | 34 |
| Phx Technologies Corp. | 33 |
| United States Surgical, A Division of Tyco Healthc | 30 |
| Ethicon Endo-Surgery, Inc. | 28 |
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 GCJ 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 |
|---|---|---|
| Karl Storz Endoscopy America Inc | 51 | 3 |
| Ethicon Endo Surgery, LLC | 31 | 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 GCJ
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Related product codes in Gastroenterology, Urology
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.