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FDA 510(k)

COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES

K-Number: K970764 · 1997-04-22

ApplicantComeg Endoscopy
Decision Date1997-04-22
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Comeg Endoscopy. It received FDA 510(k) clearance on 1997-04-22 under 510(k) number K970764. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES?

COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES is a medical device that received FDA 510(k) clearance on 1997-04-22. The listed applicant is Comeg Endoscopy. The 510(k) number is K970764.

When did COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES receive FDA 510(k) clearance?

COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES received FDA 510(k) clearance on 1997-04-22, under 510(k) number K970764.

Who is the listed applicant for COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES?

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

What is the FDA product code for COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES?

The FDA product code for COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES is OCX.

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 Comeg Endoscopy 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.

K971881COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORSK970489COMEG ENDOSCOPY GRASPING FORCEPS

Related Devices (Code: OCX)

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.

K251986AUXILIARY WATER TUBE MAJ-855Olympus Medical Systems CorporationK251997Single-Use Biopsy Valve (MAJ-1555)Olympus Medical Systems CorporationK242586ArgoCap (200.52)Ovesco Endoscopy AGK241704Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd.K242357Water Container (MAJ-901); Water Container (MAJ-902)Olympus Medical Systems CorporationK241874Aspiration Catheter (2189)Hobbs Medical, 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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