K162421 is an FDA 510(k) clearance for the IntelliCartTM System, a Apparatus, Suction, Ward Use, Portable, Ac-powered (Class II — Special Controls, product code JCX), submitted by Dornoch Medical Systems (Riverside, US). The FDA issued a Cleared decision on December 21, 2016, 113 days after receiving the submission on August 30, 2016. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K162421 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 30, 2016 |
| Decision Date | December 21, 2016 |
| Days to Decision | 113 days |
| Submission Type | Special |
| 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 |