Triton System
K-Number: K160338 · 2016-08-05
ApplicantGauss Surgical, Inc.,
Decision Date2016-08-05
Product CodePBZ
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Triton System is a medical device manufactured by Gauss Surgical, Inc.,. It received FDA 510(k) clearance on 2016-08-05 under approval number K160338. The device is classified under product code PBZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Triton System?
Triton System is a medical device that received FDA 510(k) clearance on 2016-08-05. It is manufactured by Gauss Surgical, Inc.,. The 510(k) number is K160338.
When was Triton System approved by the FDA?
Triton System received FDA 510(k) clearance on 2016-08-05, under approval number K160338.
What company makes Triton System?
Triton System is manufactured by Gauss Surgical, Inc.,.
What is the FDA product code for Triton System?
The FDA product code for Triton System is PBZ.
Related Clinical Trials
Other Devices by Gauss Surgical, Inc.,
Related Devices (Code: PBZ)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.