GAUZE, ABSORBABLE X-RAY DETECT. LAP SPG.— 510(k) K802982

Name: FDA 510(k) clearance K802982
Creator: U.S. Food and Drug Administration
Published: 1980-12-19

Substantially Equivalent

Stanford Laboratories

FDA 510(k) clearance K802982 for GAUZE, ABSORBABLE X-RAY DETECT. LAP SPG., Substantially Equivalent on 1980-12-19. Applicant: Stanford Laboratories. Device class: 1.

Clearance details

Applicant: Stanford Laboratories
Product code: Code GDY
Device class: Class 1
Regulation: 21 CFR 878.4450
Advisory panel: General, Plastic Surgery
Date received: 1980-11-24
Decision date: 1980-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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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.