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

Name: FDA 510(k) clearance K003015
Creator: U.S. Food and Drug Administration
Published: 2000-12-15

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. Device class: 2.

Clearance details

Applicant: Surgical Specialties Corp
Product code: Code GAN
Device class: Class 2
Regulation: 21 CFR 878.4830
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

Download summary PDF View on FDA.gov ↗

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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.