STERILE X-RAY DETECTABLE GAUZE SPONGES— 510(k) K941522

Name: FDA 510(k) clearance K941522
Creator: U.S. Food and Drug Administration
Published: 1994-05-12

Substantially Equivalent

Cush Medical Products

FDA 510(k) clearance K941522 for STERILE X-RAY DETECTABLE GAUZE SPONGES, Substantially Equivalent on 1994-05-12. Applicant: Cush Medical Products. Device class: 1.

Clearance details

Applicant: Cush Medical Products
Product code: Code GDY
Device class: Class 1
Regulation: 21 CFR 878.4450
Advisory panel: General, Plastic Surgery
Date received: 1994-03-30
Decision date: 1994-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Piney Flats, TN, US

Download summary PDF View on FDA.gov ↗

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K955599 — STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE1996-02-22
K955322 — PROTEC X-RAY DETECTABLE GAUZE SPONGE1995-12-19
K953830 — KENSORB1995-10-03

More clearances from Cush Medical Products

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K943424 — CUSH ISLAND DRESSING1994-10-03
K940518 — C-SECTION TRAY1994-08-18
K941349 — DENTAL TRAY1994-07-26
K941645 — BIOPSY TRAY1994-07-14
K940239 — EYE TRAY1994-06-28

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.