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FDA 510(k)

SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR

K-Number: K010309 · 2001-04-18

ApplicantMutoh America Co., Ltd.
Decision Date2001-04-18
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Mutoh America Co., Ltd.. It received FDA 510(k) clearance on 2001-04-18 under 510(k) number K010309. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR?

SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR is a medical device that received FDA 510(k) clearance on 2001-04-18. The listed applicant is Mutoh America Co., Ltd.. The 510(k) number is K010309.

When did SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR receive FDA 510(k) clearance?

SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR received FDA 510(k) clearance on 2001-04-18, under 510(k) number K010309.

Who is the listed applicant for SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR?

The FDA 510(k) record lists Mutoh America Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR?

The FDA product code for SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR is LFL.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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