K251111 is an FDA 510(k) clearance for the Cary. This device is classified as a Apparatus, Suction, Ward Use, Portable, Ac-powered (Class II - Special Controls, product code JCX).
Submitted by Excitus AS (Stavanger, NO). The FDA issued a Cleared decision on May 7, 2025, 26 days after receiving the submission on April 11, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K251111 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2025 |
| Decision Date | May 07, 2025 |
| Days to Decision | 26 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | JCX - Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4780 |