K243640 is an FDA 510(k) clearance for the Trojan? Ultra Ribbed Ecstasy latex condom with lubricant (Trojan? Ultra Ribbed Ecstasy), a Condom (Class II — Special Controls, product code HIS), submitted by Church & Dwight Co., Inc. (Ewing, US). The FDA issued a Cleared decision on February 21, 2025, 88 days after receiving the submission on November 25, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K243640 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 25, 2024 |
| Decision Date | February 21, 2025 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIS — Condom |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.5300 |