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— 510(k) K160623

Substantially Equivalent

M/s. Meril Endo Surgery Private Limited.

FDA 510(k) clearance K160623 for 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, Substantially Equivalent on 2016-05-31. Applicant: M/s. Meril Endo Surgery Private Limited..

Clearance details

Applicant: M/s. Meril Endo Surgery Private Limited.
Product code: Code GAP
Advisory panel: General, Plastic Surgery
Date received: 2016-03-04
Decision date: 2016-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chala, Vapi, 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.