Surgimetrics International, Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Surgimetrics International, Ltd.” (first 1994, latest 1994), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 321 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 | 2 | 2 |
| GAP | Suture, Nonabsorbable, Silk | 1 | 1 |
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | 1 | 1 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 1 | 1 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 1 | 1 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 1 | 1 |
Review panels
Most recent Surgimetrics International, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K931914 | SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE | GAR | 1994-10-05 | 537 |
| K931919 | CATGUT SUTURE CHROMIC | GAL | 1994-03-03 | 321 |
| K931918 | CATGUT SUTURE PLAIN | GAL | 1994-03-03 | 321 |
| K931917 | SUTURE NON-ABSORBABLE SYNTHETIC POLYPROPYLENE | GAW | 1994-03-03 | 321 |
| K931916 | SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER | GAT | 1994-03-03 | 321 |
| K931915 | STAINLESS STEEL SUTURE | GAQ | 1994-03-03 | 321 |
| K931913 | SUTURE NON-ABSORBABLE SILK | GAP | 1994-03-03 | 321 |
Recalls
openFDA lists no recalls under a recalling firm named Surgimetrics International, 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 Surgimetrics International, Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Surgimetrics International, Ltd.” (first 1994, latest 1994), across 6 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 Surgimetrics International, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Surgimetrics International, Ltd. is 321 days.
Which FDA product codes appear under Surgimetrics International, Ltd.?
The most frequent FDA product codes under this applicant name are GAL (Suture, Absorbable, Natural, 2); GAP (Suture, Nonabsorbable, Silk, 1); GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, 1).
Next steps
- See all 7 Surgimetrics International, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GAL, Surgimetrics International, 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.