PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP— 510(k) K961931

Substantially Equivalent

R. K. Medical L. L. C.

FDA 510(k) clearance K961931 for PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP, Substantially Equivalent on 1996-07-29. Applicant: R. K. Medical L. L. C..

Clearance details

Applicant: R. K. Medical L. L. C.
Product code: Code GAL
Advisory panel: General, Plastic Surgery
Date received: 1996-05-17
Decision date: 1996-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

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Adverse events under product code GAL

product code GAL

Malfunction: 681
Other: 1
Total: 682

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.