K181387 is an FDA 510(k) clearance for the Pre-Formed Penile Silicone Block. This device is classified as a Elastomer, Silicone Block (Class II - Special Controls, product code MIB).
Submitted by International Medical Devices, Inc. (Beverly Hills, US). The FDA issued a Cleared decision on January 23, 2019, 243 days after receiving the submission on May 25, 2018.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 874.3620.
| 510(k) Number | K181387 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 25, 2018 |
| Decision Date | January 23, 2019 |
| Days to Decision | 243 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MIB — Elastomer, Silicone Block |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3620 |