NYLON, NONABSORBABLE SURGICAL SUTURES USP— 510(k) K001173

Name: FDA 510(k) clearance K001173
Creator: U.S. Food and Drug Administration
Published: 2000-06-23

Substantially Equivalent for Some Indications

Cp Medical

FDA 510(k) clearance K001173 for NYLON, NONABSORBABLE SURGICAL SUTURES USP, Substantially Equivalent for Some Indications on 2000-06-23. Applicant: Cp Medical. Device class: 2.

Clearance details

Applicant: Cp Medical
Product code: Code GAR
Device class: Class 2
Regulation: 21 CFR 878.5020
Advisory panel: General, Plastic Surgery
Date received: 2000-04-11
Decision date: 2000-06-23
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Portland, OR, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GAR

product code GAR

Injury: 422
Malfunction: 3,386
Other: 4
Total: 3,812

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.