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FDA 510(k)

OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU)

K-Number: K962952 · 1996-11-29

ApplicantOlympus Optical, Co.
Decision Date1996-11-29
Product CodeLBK
DecisionSubstantially Equivalent

Device Summary

OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU) is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Optical, Co.. It received FDA 510(k) clearance on 1996-11-29 under 510(k) number K962952. The device is classified under product code LBK. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU)?

OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU) is a medical device that received FDA 510(k) clearance on 1996-11-29. The listed applicant is Olympus Optical, Co.. The 510(k) number is K962952.

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

OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU) received FDA 510(k) clearance on 1996-11-29, under 510(k) number K962952.

Who is the listed applicant for OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU)?

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

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

The FDA product code for OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU) is LBK.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing 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.

K990687HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPSK982610OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT (URINARY TRACT)K971340OLYMPUS NEURO ENDOSCOPE

Related Devices (Code: LBK)

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.

K972612DISSECTRON PORTABLE UNITSatelecK884412CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA.Valleylab, Inc.K884413CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATORValleylab, Inc.K883522AMERIMED ULTRASONIC SURGICAL ASPIRATION KITAmerimed US Corp.K855138BOVIE ULTRASONIC SURGICAL SYSTEMClinical Technology Corp.K853143COOPER LASER SONICS CUSA MODEL 200Cooper Lasersonics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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