ENDOTEK ULTRA SYSTEM— 510(k) K920451

Substantially Equivalent

Surgitek

FDA 510(k) clearance K920451 for ENDOTEK ULTRA SYSTEM, Substantially Equivalent on 1992-09-17. Applicant: Surgitek. Device class: 2.

Clearance details

Applicant: Surgitek
Product code: Code FAP
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1992-02-04
Decision date: 1992-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Racine, WI, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.