K172149

Substantially Equivalent

FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture

Applicant: M/s. Meril Endo Surgery Private Limited.
Product code: GAP
Advisory panel: General, Plastic Surgery
Date received: 2017-07-17
Decision date: 2017-10-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Chala, Vapi, IN

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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.