Cleared Traditional

Lelo Hex Natural Rubber Latex Condom

K160644 · Lelo, Inc. · Obstetrics & Gynecology

Jun 2016

Decision

115d

Days

Class 2

Risk

About This 510(k) Submission

K160644 is an FDA 510(k) clearance for the Lelo 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 June 30, 2016, 115 days after receiving the submission on March 7, 2016. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number	K160644 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 07, 2016
Decision Date	June 30, 2016
Days to Decision	115 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement