Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds— 510(k) K161358

Substantially Equivalent

Surgical Instrument Service and Savings, Inc.

FDA 510(k) clearance K161358 for Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds, Substantially Equivalent on 2017-08-03. Applicant: Surgical Instrument Service and Savings, Inc..

Clearance details

Applicant: Surgical Instrument Service and Savings, Inc.
Product code: Code JCX
Advisory panel: General, Plastic Surgery
Date received: 2016-05-16
Decision date: 2017-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, OR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.