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FDA 510(k)

ENDOBRUSH(TM) DEVICE; OMNIBRUSH

K-Number: K897070 · 1990-09-10

ApplicantIntl. Cytobrush, Inc.
Decision Date1990-09-10
Product CodeHFE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ENDOBRUSH(TM) DEVICE; OMNIBRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Cytobrush, Inc.. It received FDA 510(k) clearance on 1990-09-10 under 510(k) number K897070. The device is classified under product code HFE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOBRUSH(TM) DEVICE; OMNIBRUSH?

ENDOBRUSH(TM) DEVICE; OMNIBRUSH is a medical device that received FDA 510(k) clearance on 1990-09-10. The listed applicant is Intl. Cytobrush, Inc.. The 510(k) number is K897070.

When did ENDOBRUSH(TM) DEVICE; OMNIBRUSH receive FDA 510(k) clearance?

ENDOBRUSH(TM) DEVICE; OMNIBRUSH received FDA 510(k) clearance on 1990-09-10, under 510(k) number K897070.

Who is the listed applicant for ENDOBRUSH(TM) DEVICE; OMNIBRUSH?

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

What is the FDA product code for ENDOBRUSH(TM) DEVICE; OMNIBRUSH?

The FDA product code for ENDOBRUSH(TM) DEVICE; OMNIBRUSH is HFE.

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 Intl. Cytobrush, 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.

K895675PAP SMEAR TRAYK862322CHLAMYDIA KIT, STD KITK861389PAP SMEAR KIT

Related Devices (Code: HFE)

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.

K240595Utepreva Endometrial Sampler (UP01)Utepreva, LLCK170603Tao Brush I.U.M.C. Endometrial SamplerCook IncorporatedK112763MATRIXBRUSH ENDOMETRIAL SAMPLERPost Oak Innovations, Inc.K082066TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLERCook Urological, Inc.K941298IUMC ENDOMETRIAL SAMPLERCook Ob/GynK911620STOVALL ENDOMETRIAL BRUSHCook Ob/Gyn

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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