TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE— 510(k) K041514

Substantially Equivalent

Sutures India Private Limited

FDA 510(k) clearance K041514 for TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE, Substantially Equivalent on 2005-06-03. Applicant: Sutures India Private Limited.

Clearance details

Applicant: Sutures India Private Limited
Product code: Code GAP
Advisory panel: General, Plastic Surgery
Date received: 2004-06-07
Decision date: 2005-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bangalore, IN

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAP

product code GAP

Death: 3
Injury: 491
Malfunction: 2,253
Total: 2,747

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.