Triton Sponge System— 510(k) K163507

Substantially Equivalent

Gauss Surgical, Inc.,

FDA 510(k) clearance K163507 for Triton Sponge System, Substantially Equivalent on 2017-04-25. Applicant: Gauss Surgical, Inc.,. Device class: 2.

Clearance details

Applicant: Gauss Surgical, Inc.,
Product code: Code PBZ
Device class: Class 2
Regulation: 21 CFR 880.2750
Advisory panel: General Hospital
Date received: 2016-12-14
Decision date: 2017-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Altos, 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.