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FDA 510(k)

CORTEK URETHEROSCOPE

K-Number: K000200 · 2000-03-03

ApplicantCortek Endoscopy, Inc.
Decision Date2000-03-03
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CORTEK URETHEROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Cortek Endoscopy, Inc.. It received FDA 510(k) clearance on 2000-03-03 under 510(k) number K000200. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORTEK URETHEROSCOPE?

CORTEK URETHEROSCOPE is a medical device that received FDA 510(k) clearance on 2000-03-03. The listed applicant is Cortek Endoscopy, Inc.. The 510(k) number is K000200.

When did CORTEK URETHEROSCOPE receive FDA 510(k) clearance?

CORTEK URETHEROSCOPE received FDA 510(k) clearance on 2000-03-03, under 510(k) number K000200.

Who is the listed applicant for CORTEK URETHEROSCOPE?

The FDA 510(k) record lists Cortek Endoscopy, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORTEK URETHEROSCOPE?

The FDA product code for CORTEK URETHEROSCOPE is FGB.

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 Cortek Endoscopy, Inc. 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.

K000199CORTEK MINI LAPAROSCOPEK000198CORTEK ARTHROSCOPEK000202CORTEK LAPAROSCOPESK000197CORTEK CYSTOSCOPE

Related Devices (Code: FGB)

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.

K261447CVAC® Aspiration SystemCalyxo, Inc.K262488Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)Guangzhou Red Pine Medical Instrument Co., Ltd.K261153LithoVue Elite Digital Flexible Ureteroscope SystemBoston Scientific CorporationK262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)Scivita Medical Technology Co., Ltd.K253505Zamenix™ PRoen Surgical, Inc.K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)MacroLux Medical Technology Co., Ltd.

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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