LUKENS NYLON SURGICAL SUTURE— 510(k) K930943

Name: FDA 510(k) clearance K930943
Creator: U.S. Food and Drug Administration
Published: 1993-12-17

Substantially Equivalent

Lukens Medical Corp.

FDA 510(k) clearance K930943 for LUKENS NYLON SURGICAL SUTURE, Substantially Equivalent on 1993-12-17. Applicant: Lukens Medical Corp.. Device class: 2.

Clearance details

Applicant: Lukens Medical Corp.
Product code: Code GAR
Device class: Class 2
Regulation: 21 CFR 878.5020
Advisory panel: General, Plastic Surgery
Date received: 1993-02-23
Decision date: 1993-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Lukens Medical Corp.

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K965162 — LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P.1997-02-12
K930940 — LUKENS STAINLESS STEEL SURGICAL SUTURE1993-12-17
K930941 — LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE1993-12-17
K930942 — LUKENS SILK SURGICAL SUTURE1993-12-17
K930944 — LUKENS SURGICAL GUT SUTURE1993-12-17

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.