Cleared Special

LELO RESPECT HEX Natural Rubber Latex Condom

K162511 · Lelo, Inc. · Obstetrics & Gynecology

Jan 2017

Decision

127d

Days

Class 2

Risk

About This 510(k) Submission

K162511 is an FDA 510(k) clearance for the LELO RESPECT HEX Natural Rubber Latex Condom, a Condom (Class II — Special Controls, product code HIS), submitted by Lelo, Inc. (San Jose, US). The FDA issued a Cleared decision on January 13, 2017, 127 days after receiving the submission on September 8, 2016. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number	K162511 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 08, 2016
Decision Date	January 13, 2017
Days to Decision	127 days
Submission Type	Special
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement