SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD— 510(k) K003015

Substantially Equivalent

Surgical Specialties Corp

FDA 510(k) clearance K003015 for SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD, Substantially Equivalent on 2000-12-15. Applicant: Surgical Specialties Corp.

Clearance details

Applicant: Surgical Specialties Corp
Product code: Code GAN
Advisory panel: General, Plastic Surgery
Date received: 2000-09-27
Decision date: 2000-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reading, PA, US

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Adverse events under product code GAN

product code GAN

Injury: 599
Malfunction: 1,658
Total: 2,257

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.