Arc Medical Supplies (Beijing) Co, Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Arc Medical Supplies (Beijing) Co, Ltd.” (first 2000, latest 2002), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 70 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 |
|---|---|---|---|
| GAL | Suture, Absorbable, Natural | 1 | 1 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 1 | 1 |
| GAP | Suture, Nonabsorbable, Silk | 1 | 1 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 1 | 1 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 1 | 1 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 1 | 1 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | 1 | 1 |
Review panels
Most recent Arc Medical Supplies (Beijing) Co, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022666 | PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P. | NEW | 2002-10-09 | 61 |
| K022664 | PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P. | GAM | 2002-09-10 | 32 |
| K000542 | PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP | GAL | 2000-04-28 | 71 |
| K000541 | SILK NONABSORBABLE SURGICAL SUTURES, USP | GAP | 2000-04-28 | 71 |
| K000540 | POLYESTER NONABSORBABLE SURGICAL SUTURES, USP | GAT | 2000-04-27 | 70 |
| K000539 | NYLON NONABSORBABLE SURGICAL SUTURES, USP | GAR | 2000-04-27 | 70 |
| K000537 | POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP | GAW | 2000-04-27 | 70 |
Recalls
openFDA lists no recalls under a recalling firm named Arc Medical Supplies (Beijing) Co, 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 Arc Medical Supplies (Beijing) Co, Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Arc Medical Supplies (Beijing) Co, Ltd.” (first 2000, latest 2002), across 7 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 Arc Medical Supplies (Beijing) Co, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Arc Medical Supplies (Beijing) Co, Ltd. is 70 days.
Which FDA product codes appear under Arc Medical Supplies (Beijing) Co, Ltd.?
The most frequent FDA product codes under this applicant name are GAL (Suture, Absorbable, Natural, 1); GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid, 1); GAP (Suture, Nonabsorbable, Silk, 1).
Next steps
- See all 7 Arc Medical Supplies (Beijing) Co, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GAL, Arc Medical Supplies (Beijing) Co, 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.