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FDA 510(k)

Tao Brush I.U.M.C. Endometrial Sampler

K-Number: K170603 · 2017-05-24

ApplicantCook Incorporated
Decision Date2017-05-24
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 Incorporated. It received FDA 510(k) clearance on 2017-05-24 under 510(k) number K170603. 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 2017-05-24. The listed applicant is Cook Incorporated. The 510(k) number is K170603.

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 2017-05-24, under 510(k) number K170603.

Who is the listed applicant for Tao Brush I.U.M.C. Endometrial Sampler?

The FDA 510(k) record lists Cook Incorporated 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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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.

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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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