LYOCELL WOUND DRESSING/SURGICAL SPONGE— 510(k) K972458

Name: FDA 510(k) clearance K972458
Creator: U.S. Food and Drug Administration
Published: 1997-09-19

Substantially Equivalent

Courtaulds Fibers, Inc.

FDA 510(k) clearance K972458 for LYOCELL WOUND DRESSING/SURGICAL SPONGE, Substantially Equivalent on 1997-09-19. Applicant: Courtaulds Fibers, Inc.. Device class: Unclassified.

Clearance details

Applicant: Courtaulds Fibers, Inc.
Product code: Code MGP
Device class: Unclassified
Advisory panel: Unknown
Date received: 1997-07-01
Decision date: 1997-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Axis, AL, US

Download summary PDF View on FDA.gov ↗

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K932846 — TENCEL X-RAY DETECTABLE SPONGES/LAP PADS1993-12-09
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Adverse events under product code MGP

product code MGP

Other: 1
Total: 1

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.