TONSIL SPONGE, X-RAY DETECTABLE, W/STRING— 510(k) K882709

Name: FDA 510(k) clearance K882709
Creator: U.S. Food and Drug Administration
Published: 1988-08-03

Substantially Equivalent

Bioseal

FDA 510(k) clearance K882709 for TONSIL SPONGE, X-RAY DETECTABLE, W/STRING, Substantially Equivalent on 1988-08-03. Applicant: Bioseal. Device class: 1.

Clearance details

Applicant: Bioseal
Product code: Code GDY
Device class: Class 1
Regulation: 21 CFR 878.4450
Advisory panel: General, Plastic Surgery
Date received: 1988-06-27
Decision date: 1988-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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K953830 — KENSORB1995-10-03

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K882696 — DERMICEL, MONTGOMERY STRAP1988-08-26
K882694 — FIXATION DEVICE, TRACH TUBE1988-08-15
K882707 — GAUZE PACKING, X-RAY DETECTABLE1988-08-03

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.