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FDA 510(k)

DX101 ULTRASONIC SURGICAL SYSTEM

K-Number: K880814 · 1988-04-13

ApplicantNiic U.S.A., Inc.
Decision Date1988-04-13
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

DX101 ULTRASONIC SURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Niic U.S.A., Inc.. It received FDA 510(k) clearance on 1988-04-13 under 510(k) number K880814. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DX101 ULTRASONIC SURGICAL SYSTEM?

DX101 ULTRASONIC SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 1988-04-13. The listed applicant is Niic U.S.A., Inc.. The 510(k) number is K880814.

When did DX101 ULTRASONIC SURGICAL SYSTEM receive FDA 510(k) clearance?

DX101 ULTRASONIC SURGICAL SYSTEM received FDA 510(k) clearance on 1988-04-13, under 510(k) number K880814.

Who is the listed applicant for DX101 ULTRASONIC SURGICAL SYSTEM?

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

What is the FDA product code for DX101 ULTRASONIC SURGICAL SYSTEM?

The FDA product code for DX101 ULTRASONIC SURGICAL SYSTEM is LFL.

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Other records listing Niic U.S.A., Inc. 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.

K902133MODEL IS102S ND:YAG SURGICAL LASER SYSTEMK901205MODELS IR103,IR107,IR104,IR205 (ADD'L APPLICATION)K902063NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEMK901204EXPANDED MARKETING OF MODELS IR104 & IR205 LASERSK900185NIIC MODEL: DX901 ASPIRATION SYSTEMK896988NIIC LASER SYSTEM

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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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