Sutures India Private Limited: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Sutures India Private Limited” (first 2005, latest 2005), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 360 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 |
|---|---|---|---|
| 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 |
Review panels
Most recent Sutures India Private Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041514 | TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE | GAP | 2005-06-03 | 361 |
| K041511 | TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE | GAW | 2005-06-03 | 361 |
| K041512 | NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE | GAT | 2005-06-02 | 360 |
| K041510 | TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE | GAR | 2005-06-02 | 360 |
| K041515 | TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE | GAM | 2005-04-08 | 305 |
Recalls
openFDA lists no recalls under a recalling firm named Sutures India Private Limited.
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.
- Sutures , Ltd. (11 510(k)s)
- Sutures India Pvt., Ltd. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sutures India Private Limited?
FDA lists 5 510(k) clearances under the applicant name “Sutures India Private Limited” (first 2005, latest 2005), 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 Sutures India Private Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sutures India Private Limited is 360 days.
Which FDA product codes appear under Sutures India Private Limited?
The most frequent FDA product codes under this applicant name are GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid, 1); GAP (Suture, Nonabsorbable, Silk, 1); GAR (Suture, Nonabsorbable, Synthetic, Polyamide, 1).
Next steps
- See all 5 Sutures India Private Limited clearances with predicates and recalls
- Run predicate analysis for product code GAM, Sutures India Private Limited'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.