TENCEL X-RAY DETECTABLE SPONGES/LAP PADS— 510(k) K932846

Name: FDA 510(k) clearance K932846
Creator: U.S. Food and Drug Administration
Published: 1993-12-09

Substantially Equivalent

Courtaulds Fibers, Inc.

FDA 510(k) clearance K932846 for TENCEL X-RAY DETECTABLE SPONGES/LAP PADS, Substantially Equivalent on 1993-12-09. Applicant: Courtaulds Fibers, Inc.. Device class: 1.

Clearance details

Applicant: Courtaulds Fibers, Inc.
Product code: Code GDY
Device class: Class 1
Regulation: 21 CFR 878.4450
Advisory panel: General, Plastic Surgery
Date received: 1993-06-10
Decision date: 1993-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Axis, AL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Courtaulds Fibers, Inc.

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K972458 — LYOCELL WOUND DRESSING/SURGICAL SPONGE1997-09-19
K921227 — TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE1992-05-29

Adverse events under product code GDY

product code GDY

Malfunction: 764
Total: 764

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.