X-RAY DETECTABLE GAUZE SPONGE— 510(k) K895372

Substantially Equivalent

Keilei Intl., Inc.

FDA 510(k) clearance K895372 for X-RAY DETECTABLE GAUZE SPONGE, Substantially Equivalent on 1989-11-03. Applicant: Keilei Intl., Inc..

Clearance details

Applicant: Keilei Intl., Inc.
Product code: Code GDY
Advisory panel: General, Plastic Surgery
Date received: 1989-08-29
Decision date: 1989-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dover, NJ, US

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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.