Medical device manufacturer
Ethicon Endo Surgery, LLC
Ethicon Endo Surgery, LLC holds 184 FDA 510(k) clearances across 27 product codes. Median elapsed review time is 85 days. openFDA lists 178 recall records naming the company. FDA publishes it under 12 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 184
- Product codes
- 27
- Median review
- 85 days
- Recall records
- 178
How does FDA spell Ethicon Endo Surgery, LLC?
FDA publishes this company under 12 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| ETHICON ENDO-SURGERY, INC. | device/registrationlisting | normalised |
| ETHICON ENDO-SURGERY, LLC | device/registrationlisting | normalised |
| Ethicon Endo Surgery, LLC | device/enforcement | normalised |
| Ethicon Endo Surgery, LLC | device/recall | normalised |
| Ethicon Endo Surgery, Inc. | device/510k | normalised |
| Ethicon Endo Surgery, LLC | device/510k | normalised |
| Ethicon Endo-Surgery | device/recall | normalised |
| Ethicon Endo-Surgery | device/510k | normalised |
Showing 8 of 12.
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, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Ethicon Endo Surgery, LLC file in?
27 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| GDW | Staple, Implantable | 44 | 57 days | |
| GCJ | Laparoscope, General & Plastic Surgery | 31 | 82 days | |
| LFL | Instrument, Ultrasonic Surgical | 29 | 73 days | |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 25 | 135 days | |
| OCW | Endoscopic Tissue Approximation Device | 11 | 88 days | |
| KNW | Instrument, Biopsy | 7 | 90 days | |
| GAG | Stapler, Surgical | 5 | 91 days | |
| FZP | Clip, Implantable | 4 | 31 days | |
| GEX | Powered Laser Surgical Instrument | 4 | 52 days | |
| OXC | Mesh, Surgical, Absorbable, Staple Line Reinforcement | 3 | 130 days | |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 23 days | |
| HET | Laparoscope, Gynecologic (And Accessories) | 2 | 29 days | |
| KNQ | Dilator, Esophageal | 2 | 26 days | |
| NEU | Marker, Radiographic, Implantable | 2 | 49 days | |
| FDI | Snare, Flexible | 1 | 204 days | |
| FER | Anoscope And Accessories | 1 | 97 days | |
| FQH | Lavage, Jet | 1 | 71 days | |
| GAL | Suture, Absorbable, Natural | 1 | 30 days | |
| GBZ | Catheter, Cholangiography | 1 | 74 days | |
| GCM | Endoscope, Rigid | 1 | 78 days | |
| HIF | Insufflator, Laparoscopic | 1 | 90 days | |
| KCJ | Applicator, Ent | 1 | 49 days | |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 1 | 158 days | |
| LZA | Polymer Patient Examination Glove | 1 | 25 days | |
| MND | Ligator, Esophageal | 1 | 81 days |
Showing the 25 they file in most, of 27.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Ethicon Endo Surgery, LLC had a recall?
openFDA lists 178 recall records naming this company across its whole history, of which 1 was opened in the last 12 months and is not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-0147-2026Class IIOpen, ClassifiedGDW
The devices were shipped unsterilized.
Z-1746-2025Class IOpen, ClassifiedGDW
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-1513-2025Class IIOpen, ClassifiedNEW
Identified curing issues with the silicone during the needles manufacturing process.
Z-1514-2025Class IIOpen, ClassifiedNEW
Identified curing issues with the silicone during the needles manufacturing process.
Z-1515-2025Class IIOpen, ClassifiedNEW
Identified curing issues with the silicone during the needles manufacturing process.
Showing the 5 most recently initiated of 178.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Ethicon Endo Surgery, LLC cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| 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) | GDW | 109 | |
| K252906 | ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) | OXC | 119 | |
| 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) | GDW | 111 | |
| 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) | GDW | 55 | |
| 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) | GDW | 132 | |
| 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) | GDW | 144 | |
| K241629 | ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) | GAG | 27 | |
| K232313 | LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) | FZP | 27 | |
| K230387 | ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S) | GEI | 58 | |
| 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) | GDW | 90 |
Source: openFDA device/510k · retrieved
Where is Ethicon Endo Surgery, LLC registered?
FDA lists 2 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Ethicon Endo Surgery, LLC files next
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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.