POLYESTER X-RAY DETECTABLE STRUNG-SPONGE— 510(k) K830201

Name: FDA 510(k) clearance K830201
Creator: U.S. Food and Drug Administration
Published: 1983-02-23

Substantially Equivalent

American Medical Disposable, Inc.

FDA 510(k) clearance K830201 for POLYESTER X-RAY DETECTABLE STRUNG-SPONGE, Substantially Equivalent on 1983-02-23. Applicant: American Medical Disposable, Inc.. Device class: 1.

Clearance details

Applicant: American Medical Disposable, Inc.
Product code: Code GDY
Device class: Class 1
Regulation: 21 CFR 878.4450
Advisory panel: General, Plastic Surgery
Date received: 1983-01-20
Decision date: 1983-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K955322 — PROTEC X-RAY DETECTABLE GAUZE SPONGE1995-12-19
K953830 — KENSORB1995-10-03

More clearances from American Medical Disposable, Inc.

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K833734 — NEUROLOGICAL SPONGE ON PLASTIC STICK1984-04-23
K833735 — AN ODOR ABSORBENT BANDAGE1984-04-23
K833730 — NON ADHERENT BANDAGE/SHEET1984-01-27
K833731 — BREATHABLE OVERWRAY BANDAGE NON-ELAS1984-01-27
K833729 — ELASTIC BREATHABLE OVER-WRAP BANDAGE1983-12-30

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.