Cleared Traditional

K170603 - Tao Brush I.U.M.C. Endometrial Sampler

K170603 is an FDA 510(k) clearance for Tao Brush I.U.M.C. Endometrial Sampler, manufactured by Cook Incorporated. The device is a Class 2 Obstetrics & Gynecology device with product code HFE cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K170603 · Cook Incorporated · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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

FDA 510(k) Submission Details - K170603

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 161d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HFE Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HFE Brush, Endometrial

Devices cleared under the same product code (HFE) and FDA review panel - the closest regulatory comparables to K170603.
Utepreva Endometrial Sampler (UP01)
K240595 · Utepreva, LLC · Aug 2024
MATRIXBRUSH ENDOMETRIAL SAMPLER
K112763 · Post Oak Innovations, Inc. · Jun 2012
TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER
K082066 · Cook Urological, Inc. · Nov 2008
IUMC ENDOMETRIAL SAMPLER
K941298 · Cook Ob/Gyn · Feb 1995
STOVALL ENDOMETRIAL BRUSH
K911620 · Cook Ob/Gyn · Jun 1994