Wiltek Medical, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Wiltek Medical, Inc.” (first 1989, latest 1999), across 13 product codes in 4 review panels. Median 510(k) review time under this name: 143 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 6 | 6 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
| LQR | Dislodger, Stone, Biliary | 2 | 2 |
| BSS | Tube, Nasogastric | 1 | 1 |
| BWH | Forceps, Biopsy, Bronchoscope (Non-Rigid) | 1 | 1 |
| BYY | Tube, Aspirating, Flexible, Connecting | 1 | 1 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
| FDI | Snare, Flexible | 1 | 1 |
| FDX | Endoscopic Cytology Brush | 1 | 1 |
| FPD | Tube, Feeding | 1 | 1 |
Plus 3 more product codes.
Review panels
- Gastroenterology and Urology (16)
- General and Plastic Surgery (3)
- Ear, Nose and Throat (1)
- General Hospital (1)
Most recent Wiltek Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990231 | WILTEK HOT BIOPSY FORCEPS | KGE | 1999-04-13 | 78 |
| K922989 | WILTEK IRRIGAITON/ASPIRATION TUBE SET | BYY | 1994-02-15 | 603 |
| K930419 | WILTEK BIOPSY FORCEPS | BWH | 1993-06-01 | 126 |
| K914882 | WILTEK BALLOON CHOLANGIOGRAPHY CATHETER | FGE | 1992-01-07 | 69 |
| K914881 | WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER | FGE | 1992-01-07 | 69 |
| K914132 | WILTEK ELECTROCAUTERY ACTIVE CORD | GEI | 1991-09-25 | 12 |
| K914131 | WILTEK ELECTROCAUTERY ADAPTOR | GEI | 1991-09-25 | 12 |
| K912288 | WILTEK STANDARD CHOLANGIOGRAPHY CATHETER | FGE | 1991-09-23 | 123 |
| K912122 | CHOLANGIOGRAPHY CATHETER | FGE | 1991-09-23 | 132 |
| K910334 | ELECTROCAUTERY PROBE | GEI | 1991-02-21 | 27 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Wiltek Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Wiltek Medical, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Wiltek Medical, Inc.” (first 1989, latest 1999), across 13 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Wiltek Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wiltek Medical, Inc. is 143 days.
Which FDA product codes appear under Wiltek Medical, Inc.?
The most frequent FDA product codes under this applicant name are FGE (Stents, Drains And Dilators For The Biliary Ducts, 6); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 3); LQR (Dislodger, Stone, Biliary, 2).
Next steps
- See all 21 Wiltek Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FGE, Wiltek Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.