PIXEL APP— 510(k) K121274

Substantially Equivalent

Gauss Surgical, Inc.,

FDA 510(k) clearance K121274 for PIXEL APP, Substantially Equivalent on 2012-06-27. Applicant: Gauss Surgical, Inc.,. Device class: 1.

Clearance details

Applicant: Gauss Surgical, Inc.,
Product code: Code LWH
Device class: Class 1
Regulation: 21 CFR 880.2740
Advisory panel: General Hospital
Date received: 2012-04-27
Decision date: 2012-06-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Cupertino, CA, 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.