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

Name: FDA 510(k) clearance K961931
Creator: U.S. Food and Drug Administration
Published: 1996-07-29

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.. Device class: 2.

Clearance details

Applicant: R. K. Medical L. L. C.
Product code: Code GAL
Device class: Class 2
Regulation: 21 CFR 878.4830
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

Download summary PDF View on FDA.gov ↗

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More clearances from R. K. Medical L. L. C.

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K961925 — POLYESTER NONABSORBABLE SURGICAL SUTURES USP1996-07-29
K961389 — POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES1996-06-18
K960327 — NYLON NOABSORBABLE SURGICAL SUTURES USP1996-03-04
K960328 — SILK NONABSORBABLE SURGICAL SUTURES USP1996-03-04

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.