TAS-211/2.3 ULTRATHIN FLEXIBLE ENDOSCOPE— 510(k) K935834

Substantially Equivalent

Technology Marketing Group

FDA 510(k) clearance K935834 for TAS-211/2.3 ULTRATHIN FLEXIBLE ENDOSCOPE, Substantially Equivalent on 1994-03-07. Applicant: Technology Marketing Group.

Clearance details

Applicant: Technology Marketing Group
Product code: Code FBN
Advisory panel: Gastroenterology, Urology
Date received: 1993-12-07
Decision date: 1994-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maywood, NJ, US

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Adverse events under product code FBN

product code FBN

Death: 8
Malfunction: 951
Total: 959

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.