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FDA 510(k)

OLYMPUS SONOSURG SYSTEM

K-Number: K972114 · 1998-05-18

ApplicantThe Olympus Optical Co.
Decision Date1998-05-18
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

OLYMPUS SONOSURG SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is The Olympus Optical Co.. It received FDA 510(k) clearance on 1998-05-18 under 510(k) number K972114. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS SONOSURG SYSTEM?

OLYMPUS SONOSURG SYSTEM is a medical device that received FDA 510(k) clearance on 1998-05-18. The listed applicant is The Olympus Optical Co.. The 510(k) number is K972114.

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

OLYMPUS SONOSURG SYSTEM received FDA 510(k) clearance on 1998-05-18, under 510(k) number K972114.

Who is the listed applicant for OLYMPUS SONOSURG SYSTEM?

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

What is the FDA product code for OLYMPUS SONOSURG SYSTEM?

The FDA product code for OLYMPUS SONOSURG SYSTEM is LFL.

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Other records listing The Olympus Optical Co. 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.

K032066SONOSURG SYSTEMK030194XUES-41 ENDOSCOPIC ELECTROSURGICAL UNITK021962OLYMPUS ULTRASONIC SURGICAL SYSTEMK023984MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIESK023272DISPOSABLE ASPIRATION NEEDLE NA-200HK023767UES-30 ELECTROSURGICAL UNIT AND IT'S 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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