FDA 510(k)

Kogent Torus Ultrasonic Aspirator

K-Number: K192963 · 2020-06-19

Decision Date2020-06-19

Product CodeLFL

DecisionSubstantially Equivalent

Device Summary

Kogent Torus Ultrasonic Aspirator is a medical device manufactured by Katalyst Surgical, LLC. It received FDA 510(k) clearance on 2020-06-19 under approval number K192963. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kogent Torus Ultrasonic Aspirator?

Kogent Torus Ultrasonic Aspirator is a medical device that received FDA 510(k) clearance on 2020-06-19. It is manufactured by Katalyst Surgical, LLC. The 510(k) number is K192963.

When was Kogent Torus Ultrasonic Aspirator approved by the FDA?

Kogent Torus Ultrasonic Aspirator received FDA 510(k) clearance on 2020-06-19, under approval number K192963.

What company makes Kogent Torus Ultrasonic Aspirator?

Kogent Torus Ultrasonic Aspirator is manufactured by Katalyst Surgical, LLC.

What is the FDA product code for Kogent Torus Ultrasonic Aspirator?

The FDA product code for Kogent Torus Ultrasonic Aspirator is LFL.

Other Devices by Katalyst Surgical, LLC

K163632Katalyst Cyclophotocoagulation Probe K213610Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps

Related Devices (Code: LFL)

K161882CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation K160752HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm LengthEthicon Endo-Suregery, LLC K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC K151136HARMONIC HOOKEthicon Endo-Surgery, LLC K153299Tenex Health TX SystemTenex Health, Inc. K172691Ultrasonic GeneratorOlympus Medical Systems Corp.

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.