POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES— 510(k) K961389

Name: FDA 510(k) clearance K961389
Creator: U.S. Food and Drug Administration
Published: 1996-06-18

Substantially Equivalent for Some Indications

R. K. Medical L. L. C.

FDA 510(k) clearance K961389 for POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, Substantially Equivalent for Some Indications on 1996-06-18. Applicant: R. K. Medical L. L. C.. Device class: 2.

Clearance details

Applicant: R. K. Medical L. L. C.
Product code: Code GAW
Device class: Class 2
Regulation: 21 CFR 878.5010
Advisory panel: General, Plastic Surgery
Date received: 1996-04-10
Decision date: 1996-06-18
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Mahwah, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GAW

product code GAW

Death: 66
Injury: 1,616
Malfunction: 10,428
Total: 12,110

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.