Cleared Special

SOFTPAP CERVICAL CELL COLLECTOR

K072381 · Cytocore, Inc. · Obstetrics & Gynecology

Jan 2008

Decision

159d

Days

Class 2

Risk

About This 510(k) Submission

K072381 is an FDA 510(k) clearance for the SOFTPAP CERVICAL CELL COLLECTOR, a Spatula, Cervical, Cytological (Class II — Special Controls, product code HHT), submitted by Cytocore, Inc. (Chicago, US). The FDA issued a Cleared decision on January 30, 2008, 159 days after receiving the submission on August 24, 2007. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K072381 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 24, 2007
Decision Date	January 30, 2008
Days to Decision	159 days
Submission Type	Special
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF