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FDA 510(k)

UAS ULTRASONIC ASPIRATOR SYSTEM

K-Number: K971580 · 1997-12-09

ApplicantWells Johnson Co.
Decision Date1997-12-09
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

UAS ULTRASONIC ASPIRATOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Wells Johnson Co.. It received FDA 510(k) clearance on 1997-12-09 under 510(k) number K971580. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UAS ULTRASONIC ASPIRATOR SYSTEM?

UAS ULTRASONIC ASPIRATOR SYSTEM is a medical device that received FDA 510(k) clearance on 1997-12-09. The listed applicant is Wells Johnson Co.. The 510(k) number is K971580.

When did UAS ULTRASONIC ASPIRATOR SYSTEM receive FDA 510(k) clearance?

UAS ULTRASONIC ASPIRATOR SYSTEM received FDA 510(k) clearance on 1997-12-09, under 510(k) number K971580.

Who is the listed applicant for UAS ULTRASONIC ASPIRATOR SYSTEM?

The FDA 510(k) record lists Wells Johnson Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UAS ULTRASONIC ASPIRATOR SYSTEM?

The FDA product code for UAS ULTRASONIC ASPIRATOR SYSTEM is LFL.

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Other records listing Wells Johnson Co. 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.

K991437WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00K984448BIRCOLL BALLOON DISSECTORK945876WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHTK945500WELLS JOHNSON FIXATION SYSTEMK951519WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHTK945877WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT

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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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