K233670 is an FDA 510(k) clearance for the Ascension Silicone MCP. This device is classified as a Prosthesis, Finger, Constrained, Polymer (Class II - Special Controls, product code KYJ).
Submitted by Ascension Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on December 14, 2023, 29 days after receiving the submission on November 15, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3230.
| 510(k) Number | K233670 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2023 |
| Decision Date | December 14, 2023 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KYJ — Prosthesis, Finger, Constrained, Polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3230 |