Advance Suture, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Advance Suture, Inc.” (first 1991, latest 1991), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 345 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 |
|---|---|---|---|
| GAE | Snare, Surgical | 1 | 1 |
| GAP | Suture, Nonabsorbable, Silk | 1 | 1 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 1 | 1 |
| GAS | Suture, Nonabsorbable, Synthetic, Polyester | 1 | 1 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 1 | 1 |
Review panels
Most recent Advance Suture, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K903175 | ADVANCE SUTURE NONABSORBABLE DACRON SUTURE | GAS | 1991-07-26 | 373 |
| K903174 | ADVANCE SUTURE ABSORBABLE GUT SUTURE | GAE | 1991-07-10 | 357 |
| K905454 | ADVANCE SUTURE NONABSORBABLE SILK SUTURE | GAP | 1991-06-28 | 205 |
| K903177 | ADVANCE SUTURE NONABSORBABLE NYLON SUTURE | GAR | 1991-06-28 | 345 |
| K903176 | ADVANCE SUTURE NONABSORBABLE POLYPROPYLENE SUTURE | GAW | 1991-06-28 | 345 |
Recalls
openFDA lists no recalls under a recalling firm named Advance Suture, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Advance Medical Designs, Inc. (32 510(k)s)
- Advance Medical Device, Inc. (5 510(k)s)
- Advance Rubber, Inc. (3 510(k)s)
- Advance Corp. (1 510(k)s)
- Advance Tech Intl. (1 510(k)s)
- Advance Sentry Corporation (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Advance Suture, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Advance Suture, Inc.” (first 1991, latest 1991), 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 Advance Suture, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Advance Suture, Inc. is 345 days.
Which FDA product codes appear under Advance Suture, Inc.?
The most frequent FDA product codes under this applicant name are GAE (Snare, Surgical, 1); GAP (Suture, Nonabsorbable, Silk, 1); GAR (Suture, Nonabsorbable, Synthetic, Polyamide, 1).
Next steps
- See all 5 Advance Suture, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GAE, Advance Suture, 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, 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.