SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED— 510(k) K014021

Substantially Equivalent

Surgical Specialties Corp

FDA 510(k) clearance K014021 for SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED, Substantially Equivalent on 2002-01-28. Applicant: Surgical Specialties Corp.

Clearance details

Applicant: Surgical Specialties Corp
Product code: Code GAM
Advisory panel: General, Plastic Surgery
Date received: 2001-12-06
Decision date: 2002-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reading, PA, US

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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.