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FDA 510(k)

ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR

K-Number: K980895 · 1998-11-06

ApplicantCalifornia Institute of Tissue Eng. & Instrumenti
Decision Date1998-11-06
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR is the device name listed in this FDA 510(k) record. The listed applicant is California Institute of Tissue Eng. & Instrumenti. It received FDA 510(k) clearance on 1998-11-06 under 510(k) number K980895. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR?

ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR is a medical device that received FDA 510(k) clearance on 1998-11-06. The listed applicant is California Institute of Tissue Eng. & Instrumenti. The 510(k) number is K980895.

When did ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR receive FDA 510(k) clearance?

ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR received FDA 510(k) clearance on 1998-11-06, under 510(k) number K980895.

Who is the listed applicant for ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR?

The FDA 510(k) record lists California Institute of Tissue Eng. & Instrumenti as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR?

The FDA product code for ALLEGRO ULTRASONIC SOFT TISSUE 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

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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