Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OMEGASCOPE

K-Number: K924228 · 1993-02-26

ApplicantOmega Universal Technologies, Ltd.
Decision Date1993-02-26
Product CodeFBN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OMEGASCOPE 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 1993-02-26 under 510(k) number K924228. The device is classified under product code FBN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMEGASCOPE?

OMEGASCOPE is a medical device that received FDA 510(k) clearance on 1993-02-26. The listed applicant is Omega Universal Technologies, Ltd.. The 510(k) number is K924228.

When did OMEGASCOPE receive FDA 510(k) clearance?

OMEGASCOPE received FDA 510(k) clearance on 1993-02-26, under 510(k) number K924228.

Who is the listed applicant for OMEGASCOPE?

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 OMEGASCOPE?

The FDA product code for OMEGASCOPE is FBN.

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.

K920439OMEGA OTO NASOPHARYNGO-LARYNGOSCOPEK911090OMEGA ANGIOSCOPES (OMEGASCOPES)

Related Devices (Code: FBN)

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.

K254153Single-use Video Scope; PB Digital ControllerMirco-Tech (Nanjing) Co., Ltd.K253139Disposable Distal CapMirco-Tech (Nanjing) Co., Ltd.K251338Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)Scivita Medical Technology Co., Ltd.K251170Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital ControllerTangent Endoscopy, LLCK243535Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)Shanghai SeeGen Photoelectric Technology Co., Ltd.K241444Biliary Pancreaticobiliary Scope SystemShenzhen HugeMed Medical Technical Development 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.

↑