Cleared Traditional

Always/Tampax bladder supports

K151413 · Procter & Gamble · Obstetrics & Gynecology

Dec 2015

Decision

205d

Days

Class 2

Risk

About This 510(k) Submission

K151413 is an FDA 510(k) clearance for the Always/Tampax bladder supports, a Pessary, Vaginal (Class II — Special Controls, product code HHW), submitted by Procter & Gamble (Cincinnati, US). The FDA issued a Cleared decision on December 18, 2015, 205 days after receiving the submission on May 27, 2015. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.3575.

Submission Details

510(k) Number	K151413 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 2015
Decision Date	December 18, 2015
Days to Decision	205 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF