Cleared Traditional

V-PVP

K232125 · Vitromed GmbH · Obstetrics & Gynecology
Mar 2024
Decision
247d
Days
Class 2
Risk

About This 510(k) Submission

K232125 is an FDA 510(k) clearance for the V-PVP, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Vitromed GmbH (Langenfeld, DE). The FDA issued a Cleared decision on March 20, 2024, 247 days after receiving the submission on July 17, 2023. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number K232125 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2023
Decision Date March 20, 2024
Days to Decision 247 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MQL — Media, Reproductive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.6180

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