Cleared Traditional

FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1

K051294 · Femspec LLC · Obstetrics & Gynecology

Dec 2005

Decision

217d

Days

Class 2

Risk

About This 510(k) Submission

K051294 is an FDA 510(k) clearance for the FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1, a Curette, Suction, Endometrial (and Accessories) (Class II — Special Controls, product code HHK), submitted by Femspec LLC (Port Townsend, US). The FDA issued a Cleared decision on December 21, 2005, 217 days after receiving the submission on May 18, 2005. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1175.

Submission Details

510(k) Number	K051294 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 18, 2005
Decision Date	December 21, 2005
Days to Decision	217 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement