FiXcision— 510(k) K182664

Substantially Equivalent

Agency For Medical Innovations GmbH

FDA 510(k) clearance K182664 for FiXcision, Substantially Equivalent on 2018-12-07. Applicant: Agency For Medical Innovations GmbH. Device class: 1.

Clearance details

Applicant: Agency For Medical Innovations GmbH
Product code: Code KOA
Device class: Class 1
Regulation: 21 CFR 876.4730
Advisory panel: Gastroenterology, Urology
Date received: 2018-09-25
Decision date: 2018-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Feldkirch, AT

Download summary PDF View on FDA.gov ↗

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