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FDA 510(k)

STAYEREC SYSTEM(TM)

K-Number: K901318 · 1990-05-04

ApplicantOsbon Medical Systems, Ltd.
Decision Date1990-05-04
Product CodeLKY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STAYEREC SYSTEM(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Osbon Medical Systems, Ltd.. It received FDA 510(k) clearance on 1990-05-04 under 510(k) number K901318. The device is classified under product code LKY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAYEREC SYSTEM(TM)?

STAYEREC SYSTEM(TM) is a medical device that received FDA 510(k) clearance on 1990-05-04. The listed applicant is Osbon Medical Systems, Ltd.. The 510(k) number is K901318.

When did STAYEREC SYSTEM(TM) receive FDA 510(k) clearance?

STAYEREC SYSTEM(TM) received FDA 510(k) clearance on 1990-05-04, under 510(k) number K901318.

Who is the listed applicant for STAYEREC SYSTEM(TM)?

The FDA 510(k) record lists Osbon Medical Systems, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STAYEREC SYSTEM(TM)?

The FDA product code for STAYEREC SYSTEM(TM) is LKY.

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 Osbon Medical Systems, 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.

K912736ERECAID(R) SYSTEM PLUSK896207OSBON PERSONAL LUBRICANTK895406OSBON PERSONAL LUBRICANT

Related Devices (Code: LKY)

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.

K041573NANMA VACUUM PUMP PROXZEK MODEL 2M9498SNanma Mfg Co., Ltd.K032776VACURECT VACUUM CONSTRICTION DEVICEVacurect Manufacturing (Pty) , Ltd.K030119NANMA ADJUSTABLE CONSTRICTION RINGNanma Mfg Co., Ltd.K030913NANMA VACUUM PUMPNanma Mfg Co., Ltd.K013113MODIFICATION TO NANMA VACUUM PUMPNanma Mfg Co., Ltd.K013051NANMA ADJUSTABLE CONSTRICTION RINGNanma Mfg Co., Ltd.

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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