510(k) K161358

Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds by Surgical Instrument Service and Savings, Inc. — Product Code JCX

K161358 is an FDA 510(k) premarket notification submitted by Surgical Instrument Service and Savings, Inc. for the device "Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds". The FDA issued a decision of Substantially Equivalent on August 3, 2017. The device falls under product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered), a Class II device regulated under 21 CFR 878.4780. Surgical Instrument Service and Savings, Inc. has at least 10 other 510(k) clearances on record.