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FDA 510(k)

OMNISONICS ULTRASONIC PROBES

K-Number: K993628 · 1999-12-15

ApplicantOmnisonics Medical Technologies
Decision Date1999-12-15
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

OMNISONICS ULTRASONIC PROBES is the device name listed in this FDA 510(k) record. The listed applicant is Omnisonics Medical Technologies. It received FDA 510(k) clearance on 1999-12-15 under 510(k) number K993628. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNISONICS ULTRASONIC PROBES?

OMNISONICS ULTRASONIC PROBES is a medical device that received FDA 510(k) clearance on 1999-12-15. The listed applicant is Omnisonics Medical Technologies. The 510(k) number is K993628.

When did OMNISONICS ULTRASONIC PROBES receive FDA 510(k) clearance?

OMNISONICS ULTRASONIC PROBES received FDA 510(k) clearance on 1999-12-15, under 510(k) number K993628.

Who is the listed applicant for OMNISONICS ULTRASONIC PROBES?

The FDA 510(k) record lists Omnisonics Medical Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMNISONICS ULTRASONIC PROBES?

The FDA product code for OMNISONICS ULTRASONIC PROBES is LFL.

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Other records listing Omnisonics Medical Technologies 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.

K083335MODIFIED OMNIWAVE ENDOVASCULAR SYSTEMK071762OMNIWAVE ENDOVASCULAR SYSTEMK052428RESOLUTION ENDOVASCULAR SYSTEMK041705RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2K003824OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STIK993445OMNISONIC ENDOSCOPIC DEFLECTOR

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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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