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FDA 510(k)

SONOTOME ULTRASONIC ASPIRATOR TIPS

K-Number: K010637 · 2001-04-20

ApplicantSynergetics, Inc.
Decision Date2001-04-20
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

SONOTOME ULTRASONIC ASPIRATOR TIPS is the device name listed in this FDA 510(k) record. The listed applicant is Synergetics, Inc.. It received FDA 510(k) clearance on 2001-04-20 under 510(k) number K010637. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOTOME ULTRASONIC ASPIRATOR TIPS?

SONOTOME ULTRASONIC ASPIRATOR TIPS is a medical device that received FDA 510(k) clearance on 2001-04-20. The listed applicant is Synergetics, Inc.. The 510(k) number is K010637.

When did SONOTOME ULTRASONIC ASPIRATOR TIPS receive FDA 510(k) clearance?

SONOTOME ULTRASONIC ASPIRATOR TIPS received FDA 510(k) clearance on 2001-04-20, under 510(k) number K010637.

Who is the listed applicant for SONOTOME ULTRASONIC ASPIRATOR TIPS?

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

What is the FDA product code for SONOTOME ULTRASONIC ASPIRATOR TIPS?

The FDA product code for SONOTOME ULTRASONIC ASPIRATOR TIPS 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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