NYLON NOABSORBABLE SURGICAL SUTURES USP— 510(k) K960327

Name: FDA 510(k) clearance K960327
Creator: U.S. Food and Drug Administration
Published: 1996-03-04

Substantially Equivalent for Some Indications

R. K. Medical L. L. C.

FDA 510(k) clearance K960327 for NYLON NOABSORBABLE SURGICAL SUTURES USP, Substantially Equivalent for Some Indications on 1996-03-04. Applicant: R. K. Medical L. L. C.. Device class: 2.

Clearance details

Applicant: R. K. Medical L. L. C.
Product code: Code GAR
Device class: Class 2
Regulation: 21 CFR 878.5020
Advisory panel: General, Plastic Surgery
Date received: 1996-01-24
Decision date: 1996-03-04
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Mahwah, NJ, US

Download summary PDF View on FDA.gov ↗

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

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.