K160644 is an FDA 510(k) clearance for the Lelo Hex Natural Rubber Latex Condom. This device is classified as 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 FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K160644 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | HIS - Condom |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5300 |