Clearance Summary
Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds received FDA 510(k) clearance under submission number K161358, sponsored by Surgical Instrument Service and Savings, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2017-08-03.
- Submission: K161358
- Applicant / Sponsor: Surgical Instrument Service and Savings, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4780
- Decision date: 2017-08-03
Classification & Regulation
This clearance is catalogued under FDA product code JCX and 21 CFR 878.4780, within the General, Plastic Surgery review panel as a Class II device.