ARTSMedia Semen Wash Medium— 510(k) K241095

Name: FDA 510(k) clearance K241095
Creator: U.S. Food and Drug Administration
Published: 2024-12-18

Substantially Equivalent

Artsmedia Denmark Aps

FDA 510(k) clearance K241095 for ARTSMedia Semen Wash Medium, Substantially Equivalent on 2024-12-18. Applicant: Artsmedia Denmark Aps. Device class: 2.

Clearance details

Applicant: Artsmedia Denmark Aps
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2024-04-22
Decision date: 2024-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Virum, DK

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQL

view all

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 Artsmedia Denmark Aps

view all

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