BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY— 510(k) K915816

Name: FDA 510(k) clearance K915816
Creator: U.S. Food and Drug Administration
Published: 1992-03-27

Substantially Equivalent

Gi Supply

FDA 510(k) clearance K915816 for BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY, Substantially Equivalent on 1992-03-27. Applicant: Gi Supply. Device class: 2.

Clearance details

Applicant: Gi Supply
Product code: Code EOQ
Device class: Class 2
Regulation: 21 CFR 874.4680
Advisory panel: Ear, Nose, Throat
Date received: 1991-12-30
Decision date: 1992-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camp Hill, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.