Cleared Traditional

K243638 - MV Flow Aspiration Pump (MVFLOWPMP01) (FDA 510(k) Clearance)

K243638 · Microvention · General & Plastic Surgery device

Jun 2025

Decision

200d

Days

Class 2

Risk

K243638 is an FDA 510(k) clearance for the MV Flow Aspiration Pump (MVFLOWPMP01). This device is classified as a Apparatus, Suction, Ward Use, Portable, Ac-powered (Class II - Special Controls, product code JCX).

Submitted by Microvention (Aliso Viejo, US). The FDA issued a Cleared decision on June 13, 2025, 200 days after receiving the submission on November 25, 2024.

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

Submission Details

510(k) Number	K243638 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 25, 2024
Decision Date	June 13, 2025
Days to Decision	200 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF