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FDA 510(k)

MATRIXBRUSH ENDOMETRIAL SAMPLER

K-Number: K112763 · 2012-06-18

ApplicantPost Oak Innovations, Inc.
Decision Date2012-06-18
Product CodeHFE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MATRIXBRUSH ENDOMETRIAL SAMPLER is the device name listed in this FDA 510(k) record. The listed applicant is Post Oak Innovations, Inc.. It received FDA 510(k) clearance on 2012-06-18 under 510(k) number K112763. 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 MATRIXBRUSH ENDOMETRIAL SAMPLER?

MATRIXBRUSH ENDOMETRIAL SAMPLER is a medical device that received FDA 510(k) clearance on 2012-06-18. The listed applicant is Post Oak Innovations, Inc.. The 510(k) number is K112763.

When did MATRIXBRUSH ENDOMETRIAL SAMPLER receive FDA 510(k) clearance?

MATRIXBRUSH ENDOMETRIAL SAMPLER received FDA 510(k) clearance on 2012-06-18, under 510(k) number K112763.

Who is the listed applicant for MATRIXBRUSH ENDOMETRIAL SAMPLER?

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

What is the FDA product code for MATRIXBRUSH ENDOMETRIAL SAMPLER?

The FDA product code for MATRIXBRUSH ENDOMETRIAL SAMPLER is HFE.

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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 IncorporatedK082066TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLERCook Urological, 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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