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FDA 510(k)

OLYMPUS ULTRASONIC SURGICAL SYSTEM

K-Number: K031305 · 2003-09-23

ApplicantOlympus Optical Co., Ltd.
Decision Date2003-09-23
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

OLYMPUS ULTRASONIC SURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Optical Co., Ltd.. It received FDA 510(k) clearance on 2003-09-23 under 510(k) number K031305. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS ULTRASONIC SURGICAL SYSTEM?

OLYMPUS ULTRASONIC SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 2003-09-23. The listed applicant is Olympus Optical Co., Ltd.. The 510(k) number is K031305.

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

OLYMPUS ULTRASONIC SURGICAL SYSTEM received FDA 510(k) clearance on 2003-09-23, under 510(k) number K031305.

Who is the listed applicant for OLYMPUS ULTRASONIC SURGICAL SYSTEM?

The FDA 510(k) record lists Olympus Optical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Other records listing Olympus Optical Co., Ltd. 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.

K033225EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENTK031648VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VK032092OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPEK031347ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8K024138HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECEK021852OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIES

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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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