ENDO BITE BLOCK— 510(k) K833491

Substantially Equivalent

American Endoscopy, Inc.

FDA 510(k) clearance K833491 for ENDO BITE BLOCK, Substantially Equivalent on 1984-04-25. Applicant: American Endoscopy, Inc..

Clearance details

Applicant: American Endoscopy, Inc.
Product code: Code KTI
Advisory panel: Ear, Nose, Throat
Date received: 1983-10-07
Decision date: 1984-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code KTI

product code KTI

Malfunction: 642
Total: 642

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.