FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin— 510(k) K242640

Name: FDA 510(k) clearance K242640
Creator: U.S. Food and Drug Administration
Published: 2025-05-30

Substantially Equivalent

Fertipro NV

FDA 510(k) clearance K242640 for FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin, Substantially Equivalent on 2025-05-30. Applicant: Fertipro NV. Device class: 2.

Clearance details

Applicant: Fertipro NV
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2024-09-03
Decision date: 2025-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beernem, BE

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 Fertipro NV

view all

K221547 — InActiv Blue2024-06-11
K070135 — VITRIFREEZE MEDIUM; VITRITHAW MEDIUM2007-08-16
K053494 — OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE2006-03-23

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