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FDA 510(k)

OMEGA ANGIOSCOPES (OMEGASCOPES)

K-Number: K911090 · 1991-07-31

ApplicantOmega Universal Technologies, Ltd.
Decision Date1991-07-31
Product CodeLYK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OMEGA ANGIOSCOPES (OMEGASCOPES) is the device name listed in this FDA 510(k) record. The listed applicant is Omega Universal Technologies, Ltd.. It received FDA 510(k) clearance on 1991-07-31 under 510(k) number K911090. The device is classified under product code LYK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMEGA ANGIOSCOPES (OMEGASCOPES)?

OMEGA ANGIOSCOPES (OMEGASCOPES) is a medical device that received FDA 510(k) clearance on 1991-07-31. The listed applicant is Omega Universal Technologies, Ltd.. The 510(k) number is K911090.

When did OMEGA ANGIOSCOPES (OMEGASCOPES) receive FDA 510(k) clearance?

OMEGA ANGIOSCOPES (OMEGASCOPES) received FDA 510(k) clearance on 1991-07-31, under 510(k) number K911090.

Who is the listed applicant for OMEGA ANGIOSCOPES (OMEGASCOPES)?

The FDA 510(k) record lists Omega Universal Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMEGA ANGIOSCOPES (OMEGASCOPES)?

The FDA product code for OMEGA ANGIOSCOPES (OMEGASCOPES) is LYK.

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 Omega Universal Technologies, 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.

K924228OMEGASCOPEK920439OMEGA OTO NASOPHARYNGO-LARYNGOSCOPE

Related Devices (Code: LYK)

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.

K253842Vena MicroAngioscope™ SystemVena Medical Holdings CorpK251767Vena MicroAngioscope™ SystemVena Medical Holdings CorpK062340CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEMCardio-Optics, Inc.K050808CORONARY SINUS ACCESS KIT, MODEL KCS8F-01Cardio-Optics, Inc.K011793KSEA FIBERSCOPEKARL STORZ Endoscopy-America, Inc.K012724SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273Smith & Nephew, 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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