PIXEL APP— 510(k) K120473

Substantially Equivalent

Gauss Surgical, Inc.,

FDA 510(k) clearance K120473 for PIXEL APP, Substantially Equivalent on 2012-04-09. 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: 2012-02-16
Decision date: 2012-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cupertino, CA, US

Download summary PDF View on FDA.gov ↗

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K071355 — SMARTSPONGE SYSTEM2007-05-24

More clearances from Gauss Surgical, Inc.,

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