V-GRAD— 510(k) K241833

Substantially Equivalent

Vitromed GmbH

FDA 510(k) clearance K241833 for V-GRAD, Substantially Equivalent on 2025-03-21. Applicant: Vitromed GmbH. Device class: 2.

Clearance details

Applicant: Vitromed GmbH
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2024-06-25
Decision date: 2025-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Langenfeld, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQL

K254261 — Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)2026-08-28
K260248 — Ultra-Fast Warm2026-04-28
K252672 — CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)2026-02-20
K250445 — Fast Warm - NX2025-09-12
K251637 — Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA] +1 more2025-08-27

More clearances from Vitromed GmbH

K240176 — V-VITFREEZE and V-VITWARM2024-09-13
K232125 — V-PVP2024-03-20
K222606 — V-HYADASE2023-05-26
K223117 — V-SPERM WASH2023-01-31
K193285 — V-ONESTEP2020-11-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.