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FDA 510(k)

Kogent Torus Ultrasonic Aspirator

K-Number: K192963 · 2020-06-19

ApplicantKatalyst Surgical, LLC
Decision Date2020-06-19
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

Kogent Torus Ultrasonic Aspirator is the device name listed in this FDA 510(k) record. The listed applicant is Katalyst Surgical, LLC. It received FDA 510(k) clearance on 2020-06-19 under 510(k) 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. The listed applicant is Katalyst Surgical, LLC. The 510(k) number is K192963.

When did Kogent Torus Ultrasonic Aspirator receive FDA 510(k) clearance?

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

Who is the listed applicant for Kogent Torus Ultrasonic Aspirator?

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

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

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

Other records listing Katalyst Surgical, LLC 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.

K213610Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper ForcepsK163632Katalyst Cyclophotocoagulation Probe

Related Devices (Code: LFL)

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.

K261448neXus Ultrasonic Surgical Aspirator SystemMisonix, LLCK251162CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences CorporationK242894SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45)Shanghai Saints Sages Surgical Co., Ltd.K243930Sonopet iQ Ultrasonic Aspirator System (5500-050-000)Stryker InstrumentsK241700Tenex 2nd Generation SystemTrice Medical, Inc.K240493CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation

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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