FDA 510(k)

Triton System

K-Number: K160338 · 2016-08-05

Decision Date2016-08-05

Product CodePBZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Triton System is the device name listed in this FDA 510(k) record. The listed applicant is Gauss Surgical, Inc.,. It received FDA 510(k) clearance on 2016-08-05 under 510(k) 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. The listed applicant is Gauss Surgical, Inc.,. The 510(k) number is K160338.

When did Triton System receive FDA 510(k) clearance?

Triton System received FDA 510(k) clearance on 2016-08-05, under 510(k) number K160338.

Who is the listed applicant for Triton System?

The FDA 510(k) record lists Gauss Surgical, Inc., as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Triton System?

The FDA product code for Triton System is PBZ.

Other records listing Gauss Surgical, Inc., as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K163507Triton Sponge System

Related Devices (Code: PBZ)

K252282SurgiCount+ SystemStryker Instruments K232250SurgiCount+ SystemStryker Instruments K163507Triton Sponge SystemGauss Surgical, Inc.,

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.