TRANSTYMPANIC ENDOSCOPE— 510(k) K945081

Substantially Equivalent

Endooptiks, Inc.

FDA 510(k) clearance K945081 for TRANSTYMPANIC ENDOSCOPE, Substantially Equivalent on 1995-03-06. Applicant: Endooptiks, Inc..

Clearance details

Applicant: Endooptiks, Inc.
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 1994-10-17
Decision date: 1995-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Little Silver, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EOB

product code EOB

Malfunction: 6,143
Total: 6,143

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.