SUTRALON NYLON SUTURES— 510(k) K994176

Name: FDA 510(k) clearance K994176
Creator: U.S. Food and Drug Administration
Published: 2000-02-08

Substantially Equivalent

Visionary Medical Supplies, Inc.

FDA 510(k) clearance K994176 for SUTRALON NYLON SUTURES, Substantially Equivalent on 2000-02-08. Applicant: Visionary Medical Supplies, Inc.. Device class: 2.

Clearance details

Applicant: Visionary Medical Supplies, Inc.
Product code: Code GAR
Device class: Class 2
Regulation: 21 CFR 878.5020
Advisory panel: General, Plastic Surgery
Date received: 1999-12-10
Decision date: 2000-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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More clearances from Visionary Medical Supplies, Inc.

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K102592 — SUTRAZORB2011-02-03
K070243 — SUTRALENE POLYPROPYLENE SUTURES2007-04-17
K994177 — SUTRASILK SILK SUTURE2000-02-08

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.