Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sutures India Pvt., Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K081003 | TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE | Sutures India Pvt., Ltd. | 2008-06-09 | 62 | 0 |
| K081001 | PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE | Sutures India Pvt., Ltd. | 2008-06-09 | 62 | 0 |
| K081002 | MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE | Sutures India Pvt., Ltd. | 2008-06-09 | 62 | 0 |
| K060018 | TRULENE MESH | Sutures India Pvt., Ltd. | 2006-07-26 | 203 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda