Triton System

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K160338 ↗

FDA Product Code

PBZ

Device Class

Class II

Regulation

21 CFR Part 880.2750

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K163507 Active Cleared 25 Apr 2017

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• What is the Triton System used for?

  The Triton System is an image processing device intended for the estimation of external blood loss, designed for use in general hospital settings to assist clinicians in monitoring blood loss during procedures.

• Is the Triton System reusable or single-use?

  The Triton System is supplied as a reusable system, meaning it is designed for multiple uses after appropriate cleaning and disinfection between patients, as indicated in its authorization and specifications.

• How was the Triton System cleared for marketing in the United States?

  The Triton System received FDA 510(k) clearance under submission number K160338 via the traditional pathway, demonstrating substantial equivalence to a legally marketed predicate device.

• What regulatory classification does the Triton System have?

  The Triton System is classified as a Class 2 medical device under regulation number 880.2750, as specified in its FDA authorization and device listing details.

• Who manufactures the Triton System and where is it authorized for use?

  The Triton System is manufactured by Gauss Surgical, Inc. and is authorized for marketing in the United States, with its facility located in Los Altos, California.