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FDA 510(k)

TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER

K-Number: K082066 · 2008-11-07

ApplicantCook Urological, Inc.
Decision Date2008-11-07
Product CodeHFE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 2008-11-07 under 510(k) number K082066. 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 TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER?

TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER is a medical device that received FDA 510(k) clearance on 2008-11-07. The listed applicant is Cook Urological, Inc.. The 510(k) number is K082066.

When did TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER receive FDA 510(k) clearance?

TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER received FDA 510(k) clearance on 2008-11-07, under 510(k) number K082066.

Who is the listed applicant for TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER?

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

What is the FDA product code for TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER?

The FDA product code for TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER is HFE.

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Other records listing Cook Urological, Inc. as applicant

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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.K941298IUMC ENDOMETRIAL SAMPLERCook Ob/GynK911620STOVALL ENDOMETRIAL BRUSHCook Ob/GynK897070ENDOBRUSH(TM) DEVICE; OMNIBRUSHIntl. Cytobrush, Inc.

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.

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