Gauss Surgical, Inc.,
United StatesFDA applicant, unverified
- Devices
- 6
What Gauss Surgical, Inc., makes
Gauss Surgical, Inc. manufactures surgical suction and irrigation systems, including the Triton Canister System and Triton Sponge System for fluid management during procedures. Their portfolio also includes the PIXEL 3 System and associated PIXEL APP, which integrates with surgical workflows for real-time monitoring and data tracking. These devices are designed for use in operating rooms and procedural settings to enhance efficiency and reduce contamination risks.
The company’s products are regulated under the FDA’s 510(k) pathway, with devices classified as Class I and Class II. The Triton and PIXEL systems are listed in the FDA’s 510(k) database, indicating their compliance with U.S. medical device regulations. The company is headquartered in the United States.
Catalogue
Triton Canister System Ref K142801
Regimes: 510(k) Registry: 510(k)Triton System Ref K160338
Regimes: 510(k) Registry: 510(k)Pixel App Ref K120473
Regimes: 510(k) Registry: 510(k)Triton Sponge System Ref K163507
Regimes: 510(k) Registry: 510(k)Pixel 3 System Ref DEN130015
Regimes: De Novo Registry: De NovoPixel App Ref K121274
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gauss Surgical, Inc., have in the registry?
The registry currently lists 6 devices for Gauss Surgical, Inc.,. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gauss Surgical, Inc.,'s devices?
Among its 6 most recently registered devices, Gauss Surgical, Inc., has devices listed in FDA 510(k) (6 devices).
What risk classes do Gauss Surgical, Inc.,'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Gauss Surgical, Inc.,'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gauss Surgical, Inc., in the registry?
The most recently registered devices listed for Gauss Surgical, Inc., include Triton Canister System, Triton System, PIXEL APP and Triton Sponge System.