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FDA 510(k)

ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5

K-Number: K012028 · 2001-07-27

ApplicantMisonix, Inc.
Decision Date2001-07-27
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5 is the device name listed in this FDA 510(k) record. The listed applicant is Misonix, Inc.. It received FDA 510(k) clearance on 2001-07-27 under 510(k) number K012028. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5?

ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5 is a medical device that received FDA 510(k) clearance on 2001-07-27. The listed applicant is Misonix, Inc.. The 510(k) number is K012028.

When did ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5 receive FDA 510(k) clearance?

ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5 received FDA 510(k) clearance on 2001-07-27, under 510(k) number K012028.

Who is the listed applicant for ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5?

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

What is the FDA product code for ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5?

The FDA product code for ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5 is LFL.

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Other records listing Misonix, Inc. as applicant

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K221235neXus Ultrasonic Surgical Aspirator SystemK212060neXus Ultrasonic Surgical Aspirator SystemK190160neXus Ultrasonic Surgical Aspirator SystemK123980SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIESK112782MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIESK070779SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM

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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

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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