Medical device manufacturer
ETHICON, INC.
ETHICON, INC. holds 208 FDA 510(k) clearances across 52 product codes. Median elapsed review time is 86 days. openFDA lists 104 recall records naming the company. FDA publishes it under 17 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 208
- Product codes
- 52
- Median review
- 86 days
- Recall records
- 104
How does FDA spell ETHICON, INC.?
FDA publishes this company under 17 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 SARL | device/registrationlisting | normalised |
| ETHICON, INC. | device/recall | normalised |
| ETHICON, INC. | device/enforcement | normalised |
| ETHICON, INC. | device/registrationlisting | normalised |
| ETHICON, Inc. | device/510k | normalised |
| ETHICON, LLC | device/enforcement | normalised |
| ETHICON, LLC | device/recall | normalised |
| ETHICON, LLC | device/registrationlisting | normalised |
Showing 8 of 17.
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, INC. file in?
52 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 27 | 100 days | |
| FTL | Mesh, Surgical, Polymeric | 25 | 86 days | |
| GCJ | Laparoscope, General & Plastic Surgery | 18 | 63 days | |
| FZP | Clip, Implantable | 11 | 84 days | |
| HET | Laparoscope, Gynecologic (And Accessories) | 11 | 90 days | |
| GDW | Staple, Implantable | 10 | 52 days | |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | 9 | 108 days | |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 8 | 65 days | |
| GAG | Stapler, Surgical | 6 | 36 days | |
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | 6 | 51 days | |
| LDF | Electrode, Pacemaker, Temporary | 5 | 60 days | |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 4 | 54 days | |
| OMD | Cutaneous Tissue Adhesive With Mesh | 4 | 81 days | |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 3 | 36 days | |
| FTM | Mesh, Surgical | 3 | 69 days | |
| GAN | Suture, Absorbable, Synthetic | 3 | 68 days | |
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | 3 | 232 days | |
| GDO | Applier, Surgical, Clip | 3 | 63 days | |
| GEA | Cannula, Surgical, General & Plastic Surgery | 3 | 86 days | |
| PWJ | Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence | 3 | 272 days | |
| GDT | Staple, Removable (Skin) | 2 | 36 days | |
| JDR | Staple, Fixation, Bone | 2 | 288 days | |
| KGS | Retention Device, Suture | 2 | 44 days | |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | 90 days | |
| MPN | Tissue Adhesive For The Topical Approximation Of Skin | 2 | 77 days |
Showing the 25 they file in most, of 52.
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, INC. had a recall?
openFDA lists 104 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-2605-2025Class IIOpen, ClassifiedNEW
Potential for barb non-engagement.
Z-1096-2025Class IIOpen, ClassifiedGAW
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
Z-1097-2025Class IIOpen, ClassifiedGAW
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
Z-1098-2025Class IIOpen, ClassifiedGAW
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
Z-0487-2025Class IIOpen, ClassifiedGAN
Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
Showing the 5 most recently initiated of 104.
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, INC. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K253394 | Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture | GAM | 268 | |
| K252047 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices | NEW | 322 | |
| K253572 | STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device | GAW | 130 | |
| K253852 | MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture | GAM | 66 | |
| K252743 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device | GAM | 116 | |
| K243897 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture | NEW | 328 | |
| K221744 | STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device | GAM | 152 | |
| K212380 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture | NEW | 204 | |
| K213512 | DERMABOND PRINEO Skin Closure System | OMD | 35 | |
| K201996 | Monocryl Plus Antibacterial Suture | GAM | 154 |
Source: openFDA device/510k · retrieved
Where is ETHICON, INC. registered?
FDA lists 8 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, INC. files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
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.