SUTURE NONABSORBABLE- SILK, POLYESTER— 510(k) K932038

Substantially Equivalent

Surgical Specialties, Inc.

FDA 510(k) clearance K932038 for SUTURE NONABSORBABLE- SILK, POLYESTER, Substantially Equivalent on 1994-01-07. Applicant: Surgical Specialties, Inc..

Clearance details

Applicant: Surgical Specialties, Inc.
Product code: Code GAT
Advisory panel: General, Plastic Surgery
Date received: 1993-04-27
Decision date: 1994-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Readding, PA, US

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Adverse events under product code GAT

product code GAT

Death: 19
Injury: 4,163
Malfunction: 8,646
Other: 2
Total: 12,830

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.