K161358 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds. This device is classified as a Apparatus, Suction, Ward Use, Portable, Ac-powered (Class II - Special Controls, product code JCX).
Submitted by Surgical Instrument Service and Savings, Inc. (Redmond, US). The FDA issued a Cleared decision on August 3, 2017, 444 days after receiving the submission on May 16, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K161358 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2016 |
| Decision Date | August 03, 2017 |
| Days to Decision | 444 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 |