Cleared Traditional

K222552 - 120V Neptune S Rover (0711-001-000) (FDA 510(k) Clearance)

Also includes:
V2 4-Port Manifold (0750-400-000) V2 Specimen Collection Manifold Kit (0750-200-000) V2 Specimen Collection Tray (0750-210-000)
K222552 · Stryker Instruments · General & Plastic Surgery device
Dec 2022
Decision
108d
Days
Class 2
Risk

K222552 is an FDA 510(k) clearance for the 120V Neptune S Rover (0711-001-000). This device is classified as a Apparatus, Suction, Ward Use, Portable, Ac-powered (Class II - Special Controls, product code JCX).

Submitted by Stryker Instruments (Portage, US). The FDA issued a Cleared decision on December 9, 2022, 108 days after receiving the submission on August 23, 2022.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number K222552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2022
Decision Date December 09, 2022
Days to Decision 108 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code JCX — Apparatus, Suction, Ward Use, Portable, Ac-powered
Device Class Class II - Special Controls
CFR Regulation 21 CFR 878.4780