120V Neptune S Rover (0711-001-000) +3 more— 510(k) K222552

Name: FDA 510(k) clearance K222552
Creator: U.S. Food and Drug Administration
Published: 2022-12-09

Substantially Equivalent

Stryker Instruments

FDA 510(k) clearance K222552 for 120V Neptune S Rover (0711-001-000) +3 more, Substantially Equivalent on 2022-12-09. Applicant: Stryker Instruments. Device class: 2.

Clearance details

Device name as filed: 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)
Applicant: Stryker Instruments
Product code: Code JCX
Device class: Class 2
Regulation: 21 CFR 878.4780
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 ↗

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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.