Medical device manufacturer
W. L. Gore & Associates, Inc.
W. L. Gore & Associates, Inc. holds 169 FDA 510(k) clearances across 46 product codes. Median elapsed review time is 84 days. openFDA lists 29 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
- 169
- Product codes
- 46
- Median review
- 84 days
- Recall records
- 29
How does FDA spell W. L. Gore & Associates, Inc.?
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 |
|---|---|---|
| W L Gore & Associates, Inc. | device/recall | normalised |
| W L Gore & Associates, Inc. | device/enforcement | normalised |
| W. L. GORE & ASSOCIATES, INC | device/registrationlisting | normalised |
| W. L. GORE & ASSOCIATES, INC. | device/registrationlisting | normalised |
| W. L. Gore & Associates Inc. | device/enforcement | normalised |
| W. L. Gore & Associates Inc. | device/recall | normalised |
| W. L. Gore & Associates, Inc. | device/510k | normalised |
| W. L. Gore & Associates, Inc. | device/registrationlisting | 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 W. L. Gore & Associates, Inc. file in?
46 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | 37 | 61 days | |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 24 | 85 days | |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 13 | 108 days | |
| DYF | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter | 8 | 114 days | |
| DYB | Introducer, Catheter | 7 | 93 days | |
| LYC | Bone Grafting Material, Synthetic | 5 | 86 days | |
| NPK | Barrier, Synthetic, Intraoral | 5 | 132 days | |
| DQY | Catheter, Percutaneous | 4 | 109 days | |
| MOS | Coil, Magnetic Resonance, Specialty | 4 | 17 days | |
| NTE | Temporary Carotid Catheter For Embolic Capture | 4 | 65 days | |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 3 | 59 days | |
| FWP | Prosthesis, Chin, Internal | 3 | 89 days | |
| GXQ | Dura Substitute | 3 | 84 days | |
| HRX | Arthroscope | 3 | 79 days | |
| JCT | Prosthesis, Tracheal, Expandable | 3 | 64 days | |
| OXC | Mesh, Surgical, Absorbable, Staple Line Reinforcement | 3 | 29 days | |
| OXD | Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement | 3 | 54 days | |
| OXF | Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery | 3 | 86 days | |
| FTM | Mesh, Surgical | 2 | 41 days | |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 87 days | |
| MFX | Vessel Guard Or Cover, To Facilitate Revision Surgeries | 2 | 49 days | |
| MJN | Catheter, Intravascular Occluding, Temporary | 2 | 101 days | |
| OWT | Mesh, Surgical, Absorbable, Abdominal Hernia | 2 | 29 days | |
| DBY | Fab, Rhodamine, Antigen, Antiserum, Control | 1 | 73 days | |
| DWS | Instruments, Surgical, Cardiovascular | 1 | 62 days |
Showing the 25 they file in most, of 46.
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 W. L. Gore & Associates, Inc. had a recall?
openFDA lists 29 recall records naming this company across its whole history, of which 2 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-2672-2026Class IIOpen, ClassifiedMIH
Due to catheter separation
Z-0036-2026Class IIOpen, ClassifiedDSY
Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to modify existing warning to 1) further clarify techniques that may contribute to the risk of delamination, 2) Addition of delamination to device-related adverse event section.
Z-2513-2024Class IIOpen, ClassifiedFTL
Devices were labeled with an expiration date of four years and ten days rather than the validated two years.
Z-2945-2024Class IIOpen, ClassifiedPRL
Due to packaging defects, sterility assurance and heparin activity may be compromised.
Z-2946-2024Class IIOpen, ClassifiedPRL
Due to packaging defects, sterility assurance and heparin activity may be compromised.
Showing the 5 most recently initiated of 29.
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 W. L. Gore & Associates, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K250410 | GORE® Tri-Lobe Balloon Catheter | DQY | 109 | |
| K240083 | GORE® PROPATEN® Vascular Graft | DSY | 50 | |
| K232312 | GORE® PROPATEN® Vascular Graft | DSY | 160 | |
| K233551 | GORE® ACUSEAL Vascular Graft | DSY | 46 | |
| K231505 | GORE® ACUSEAL Vascular Graft | DSY | 30 | |
| K222919 | GORE® ENFORM Biomaterial | OXF | 84 | |
| K191773 | GORE BIO-A Tissue Reinforcement | OWT | 29 | |
| K180919 | GORE Tri-Lumen Catheter | DQY | 179 | |
| K181940 | GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement | OXC | 29 | |
| K173333 | GORE ENFORM Biomaterial | OXF | 164 |
Source: openFDA device/510k · retrieved
Where is W. L. Gore & Associates, Inc. registered?
FDA lists 4 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 W. L. Gore & Associates, Inc. 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.