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FDA 510(k)

Triton Sponge System

K-Number: K163507 · 2017-04-25

ApplicantGauss Surgical, Inc.,
Decision Date2017-04-25
Product CodePBZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Triton Sponge System is a medical device manufactured by Gauss Surgical, Inc.,. It received FDA 510(k) clearance on 2017-04-25 under approval number K163507. 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 Sponge System?

Triton Sponge System is a medical device that received FDA 510(k) clearance on 2017-04-25. It is manufactured by Gauss Surgical, Inc.,. The 510(k) number is K163507.

When was Triton Sponge System approved by the FDA?

Triton Sponge System received FDA 510(k) clearance on 2017-04-25, under approval number K163507.

What company makes Triton Sponge System?

Triton Sponge System is manufactured by Gauss Surgical, Inc.,.

What is the FDA product code for Triton Sponge System?

The FDA product code for Triton Sponge System is PBZ.

Related Clinical Trials

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Other Devices by Gauss Surgical, Inc.,

K160338Triton System

Related Devices (Code: PBZ)

K160338Triton SystemGauss Surgical, Inc., K232250SurgiCount+ SystemStryker Instruments K252282SurgiCount+ SystemStryker Instruments

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.

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