INSURGICAL SINGLE USE POWER EQUIPMENT— 510(k) K112599

Name: FDA 510(k) clearance K112599
Creator: U.S. Food and Drug Administration
Published: 2012-11-06

Substantially Equivalent

Insurgical, LLC

FDA 510(k) clearance K112599 for INSURGICAL SINGLE USE POWER EQUIPMENT, Substantially Equivalent on 2012-11-06. Applicant: Insurgical, LLC. Device class: 1.

Clearance details

Applicant: Insurgical, LLC
Product code: Code KIJ
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 2011-09-07
Decision date: 2012-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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