Winn Hirsch & Assoc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Winn Hirsch & Assoc.” (first 1976, latest 1988), across 8 product codes in 5 review panels. Median 510(k) review time under this name: 28 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 |
|---|---|---|---|
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 3 | 3 |
| EFQ | Gauze/Sponge, Internal | 2 | 2 |
| DTB | Permanent Pacemaker Electrode | 1 | 1 |
| FPY | Sheet, Burn | 1 | 1 |
| HOZ | Sponge, Ophthalmic | 1 | 1 |
| ITG | Bandage, Cast | 1 | 1 |
| JDQ | Cerclage, Fixation | 1 | 1 |
| LRN | Wire, Surgical | 1 | 1 |
Review panels
- General and Plastic Surgery (6)
- Orthopedic (2)
- Cardiovascular (1)
- Ophthalmic (1)
- Physical Medicine (1)
Most recent Winn Hirsch & Assoc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K880309 | TYPE 316L STAINLESS STEEL WIRE | JDQ | 1988-02-29 | 35 |
| K864375 | TYPE 316L COTTER WIRE | LRN | 1987-05-20 | 196 |
| K832214 | GAUZE CONVERSION CLASS I-NON-STERILE | EFQ | 1983-07-26 | 14 |
| K832213 | GAUZE CONVERSION CLASS II STERILE | EFQ | 1983-07-26 | 14 |
| K830511 | ZANLEX, ZAN-TEX & ZANDEX | GDY | 1983-03-17 | 28 |
| K812391 | NEUROSPONGES | GDY | 1981-11-24 | 96 |
| K812390 | NEUROSPONGE PADDIE | GDY | 1981-11-24 | 96 |
| K800195 | COTTON UNDER CAST PADDING | ITG | 1980-02-11 | 13 |
| K761155 | CELLULOSE EYE STICK | HOZ | 1976-12-16 | 17 |
| K760513 | ELECTRODE, TEMPORARY MYOCARDIAL | DTB | 1976-10-15 | 51 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Winn Hirsch & Assoc..
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 Winn Hirsch & Assoc.?
FDA lists 11 510(k) clearances under the applicant name “Winn Hirsch & Assoc.” (first 1976, latest 1988), across 8 product codes in 5 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 Winn Hirsch & Assoc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Winn Hirsch & Assoc. is 28 days.
Which FDA product codes appear under Winn Hirsch & Assoc.?
The most frequent FDA product codes under this applicant name are GDY (Gauze/Sponge, Internal, X-Ray Detectable, 3); EFQ (Gauze/Sponge, Internal, 2); DTB (Permanent Pacemaker Electrode, 1).
Next steps
- See all 11 Winn Hirsch & Assoc. clearances with predicates and recalls
- Run predicate analysis for product code GDY, Winn Hirsch & Assoc.'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.