K132671 is an FDA 510(k) clearance for the STRYKER NEPTUNE 2 WASTE MANAGMENT 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 December 20, 2013, 115 days after receiving the submission on August 27, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K132671 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 2013 |
| Decision Date | December 20, 2013 |
| Days to Decision | 115 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 |