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FDA 510(k)

CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM

K-Number: K081459 · 2008-08-13

ApplicantIntegra Radionics, Inc.
Decision Date2008-08-13
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Integra Radionics, Inc.. It received FDA 510(k) clearance on 2008-08-13 under 510(k) number K081459. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM?

CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM is a medical device that received FDA 510(k) clearance on 2008-08-13. The listed applicant is Integra Radionics, Inc.. The 510(k) number is K081459.

When did CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM receive FDA 510(k) clearance?

CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM received FDA 510(k) clearance on 2008-08-13, under 510(k) number K081459.

Who is the listed applicant for CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM?

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

What is the FDA product code for CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM?

The FDA product code for CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM is LFL.

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Other records listing Integra Radionics, Inc. as applicant

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K102258CUSA NXT EXTENDED LENGTH TIPK100096LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHARTK100417XKNIFE 5K090864CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEMK083414RADIONICS XKNIFE HDRT SYSTEMK072454INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS

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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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