SURGICAL MICROPOROUS TAPE (MICROCEL)— 510(k) K914597

Name: FDA 510(k) clearance K914597
Creator: U.S. Food and Drug Administration
Published: 1992-03-19

Substantially Equivalent

Industrias Tuk, S.A. DE C.V.

FDA 510(k) clearance K914597 for SURGICAL MICROPOROUS TAPE (MICROCEL), Substantially Equivalent on 1992-03-19. Applicant: Industrias Tuk, S.A. DE C.V.. Device class: 1.

Clearance details

Applicant: Industrias Tuk, S.A. DE C.V.
Product code: Code KGX
Device class: Class 1
Regulation: 21 CFR 880.5240
Advisory panel: General Hospital
Date received: 1991-10-16
Decision date: 1992-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: N.L., Mexico, MX

Download summary PDF View on FDA.gov ↗

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K914596 — SURGICAL CLOTH TAPE (HEALRITE)1992-03-19
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Adverse events under product code KGX

product code KGX

Injury: 1,590
Malfunction: 1,357
Other: 3
Total: 2,950

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.