K231095 is an FDA 510(k) clearance for the Tamper Evident Cap. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by International Medical Industries, Inc. (Pompano Beach, US). The FDA issued a Cleared decision on September 4, 2024, 505 days after receiving the submission on April 18, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K231095 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 2023 |
| Decision Date | September 04, 2024 |
| Days to Decision | 505 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |