K172659

Substantially Equivalent

MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture

Applicant: M/s. Meril Endo Surgery Private Limited.
Product code: GAM
Advisory panel: General, Plastic Surgery
Date received: 2017-09-05
Decision date: 2017-09-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Chala, Vapi, IN

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAM

product code GAM

Death: 45
Injury: 5,711
Malfunction: 30,744
Other: 4
Total: 36,504

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.