K203541 is an FDA 510(k) clearance for the Okamoto 002 Lubricated Polyurethane Male Condom. This device is classified as a Condom, Synthetic (Class II - Special Controls, product code MOL).
Submitted by Okamoto USA, Inc. (Stratford, US). The FDA issued a Cleared decision on February 25, 2022, 449 days after receiving the submission on December 3, 2020.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K203541 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2020 |
| Decision Date | February 25, 2022 |
| Days to Decision | 449 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MOL - Condom, Synthetic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5300 |