TAS-(VARIOUS) ULTRATHIN FLEXIBLE ENDOSCOPE— 510(k) K942388

Name: FDA 510(k) clearance K942388
Creator: U.S. Food and Drug Administration
Published: 1994-08-17

Substantially Equivalent

Technology Marketing Group

FDA 510(k) clearance K942388 for TAS-(VARIOUS) ULTRATHIN FLEXIBLE ENDOSCOPE, Substantially Equivalent on 1994-08-17. Applicant: Technology Marketing Group. Device class: 2.

Clearance details

Applicant: Technology Marketing Group
Product code: Code EOQ
Device class: Class 2
Regulation: 21 CFR 874.4680
Advisory panel: Ear, Nose, Throat
Date received: 1994-05-19
Decision date: 1994-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maywood, NJ, US

Download summary PDF View on FDA.gov ↗

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K941715 — ULTATHIN FLEXIBLE ENDOSCOPE1994-10-04
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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.