Cleared Traditional

STOVALL ENDOMETRIAL BRUSH

K911620 · Cook Ob/Gyn · Obstetrics & Gynecology
Jun 1994
Decision
1170d
Days
Class 2
Risk

About This 510(k) Submission

K911620 is an FDA 510(k) clearance for the STOVALL ENDOMETRIAL BRUSH, a Brush, Endometrial (Class II — Special Controls, product code HFE), submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on June 24, 1994, 1170 days after receiving the submission on April 11, 1991. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1100.

Submission Details

510(k) Number K911620 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1991
Decision Date June 24, 1994
Days to Decision 1170 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

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

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