Cleared Traditional

K170603 - Tao Brush I.U.M.C. Endometrial Sampler (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170603 · Cook Incorporated · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
May 2017
Decision
84d
Days
Class 2
Risk

K170603 is an FDA 510(k) clearance for the Tao Brush I.U.M.C. Endometrial Sampler. Classified as Brush, Endometrial (product code HFE), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on May 24, 2017 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1100 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cook Incorporated devices

Submission Details

510(k) Number K170603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2017
Decision Date May 24, 2017
Days to Decision 84 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 160d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HFE Brush, Endometrial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.