Foosin Medical Supplies Inc., Ltd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Foosin Medical Supplies Inc., Ltd.” (first 2008, latest 2020), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 108 days. Since 2017 the median was 90 days, against 158 days for all cleared 510(k)s in the same product codes. 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 | 3 | 302 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 132 |
| 2018 | 0 | — |
| 2019 | 2 | 90 |
| 2020 | 2 | 132 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Foosin Medical Supplies Inc., Ltd. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 158 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 5 | 5 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | 2 | 2 |
| GAP | Suture, Nonabsorbable, Silk | 1 | 1 |
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | 1 | 1 |
| NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | 1 | 1 |
Review panels
Most recent Foosin Medical Supplies Inc., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201139 | WEGO-PDO Barbed Suture | NEW | 2020-10-20 | 175 |
| K193209 | Wego-Stainless Steel | GAQ | 2020-02-19 | 90 |
| K183004 | WEGO-PGA RAPID | GAM | 2019-01-28 | 90 |
| K183001 | WEGO-PGLA RAPID | GAM | 2019-01-28 | 90 |
| K170842 | WEGO-PTFE | NBY | 2017-07-31 | 132 |
| K142810 | WEGO-PGCL Absorbable Surgical Monofilament Suture | GAM | 2014-11-14 | 46 |
| K130737 | SYNTHETIC ABSORBABLE SUTURE | GAM | 2014-01-14 | 302 |
| K130735 | SYNTHETIC ABSORBABLE SUTURE | GAM | 2014-01-14 | 302 |
| K080684 | WG-SURGICAL SUTURES WITH NEEDLE | GAP | 2008-06-09 | 91 |
| K073614 | WG-SURGICAL SUTURES WITH NEEDLE | NEW | 2008-04-30 | 126 |
Recalls
openFDA lists no recalls under a recalling firm named Foosin Medical Supplies Inc., Ltd..
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 Foosin Medical Supplies Inc., Ltd.?
FDA lists 10 510(k) clearances under the applicant name “Foosin Medical Supplies Inc., Ltd.” (first 2008, latest 2020), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Foosin Medical Supplies Inc., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Foosin Medical Supplies Inc., Ltd. is 108 days. Since 2017: 90 days, versus 158 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Foosin Medical Supplies Inc., Ltd.?
The most frequent FDA product codes under this applicant name are GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid, 5); NEW (Suture, Surgical, Absorbable, Polydioxanone, 2); GAP (Suture, Nonabsorbable, Silk, 1).
Next steps
- See all 10 Foosin Medical Supplies Inc., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GAM, Foosin Medical Supplies Inc., Ltd.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.