Cleared Traditional

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

K170603 · Cook Incorporated · Obstetrics & Gynecology
May 2017
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K170603 is an FDA 510(k) clearance for the Tao Brush I.U.M.C. Endometrial Sampler, a Brush, Endometrial (Class II — Special Controls, product code HFE), submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on May 24, 2017, 84 days after receiving the submission on March 1, 2017. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1100.

Submission Details

510(k) Number K170603 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code HFE — Brush, Endometrial
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1100