K240185 is an FDA 510(k) clearance for the Cypris eXact Suture Placement Device. This device is classified as a Carrier, Ligature (Class I - General Controls, product code GEJ).
Submitted by Cypris Medical (Chicago, US). The FDA issued a Cleared decision on May 3, 2024, 101 days after receiving the submission on January 23, 2024.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K240185 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 2024 |
| Decision Date | May 03, 2024 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GEJ - Carrier, Ligature |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |