ENDODRAPE— 510(k) K070406

Substantially Equivalent

Vortek Surgical, LLC

FDA 510(k) clearance K070406 for ENDODRAPE, Substantially Equivalent on 2007-07-30. 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: 2007-02-12
Decision date: 2007-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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