ENDODRAPE(TM)— 510(k) K080341

Substantially Equivalent

Vortek Surgical, LLC

FDA 510(k) clearance K080341 for ENDODRAPE(TM), Substantially Equivalent on 2008-07-21. Applicant: Vortek Surgical, LLC. Device class: 2.

Clearance details

Applicant: Vortek Surgical, LLC
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2008-02-08
Decision date: 2008-07-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Vortek Surgical, LLC

K070406 — ENDODRAPE2007-07-30

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