120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)— 510(k) K222552

Substantially Equivalent

Stryker Instruments

FDA 510(k) clearance K222552 for 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000), Substantially Equivalent on 2022-12-09. Applicant: Stryker Instruments.

Clearance details

Applicant: Stryker Instruments
Product code: Code JCX
Advisory panel: General, Plastic Surgery
Date received: 2022-08-23
Decision date: 2022-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portage, MI, 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.