K153407 is an FDA 510(k) clearance for the Stryker Neptune 3 Waste Management System. This device is classified as a Apparatus, Suction, Ward Use, Portable, Ac-powered (Class II - Special Controls, product code JCX).
Submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on April 25, 2016, 152 days after receiving the submission on November 25, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K153407 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 2015 |
| Decision Date | April 25, 2016 |
| Days to Decision | 152 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| 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 |