Cleared Traditional

HISTOBRUSH

K111681 · Puritan Medical Products Company, LLC · Obstetrics & Gynecology

Jan 2012

Decision

218d

Days

Class 2

Risk

About This 510(k) Submission

K111681 is an FDA 510(k) clearance for the HISTOBRUSH, a Spatula, Cervical, Cytological (Class II — Special Controls, product code HHT), submitted by Puritan Medical Products Company, LLC (Guilford, US). The FDA issued a Cleared decision on January 19, 2012, 218 days after receiving the submission on June 15, 2011. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K111681 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 15, 2011
Decision Date	January 19, 2012
Days to Decision	218 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF