cryo-GO Vitrification Device— 510(k) K241341

Name: FDA 510(k) clearance K241341
Creator: U.S. Food and Drug Administration
Published: 2024-09-26

Substantially Equivalent

Fujifilm Irvine Scientific

FDA 510(k) clearance K241341 for cryo-GO Vitrification Device, Substantially Equivalent on 2024-09-26. Applicant: Fujifilm Irvine Scientific. Device class: 2.

Clearance details

Applicant: Fujifilm Irvine Scientific
Product code: Product code MQK
Device class: Class 2
Regulation: 21 CFR 884.6160
Advisory panel: Obstetrics/Gynecology
Date received: 2024-05-13
Decision date: 2024-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQK

view all

K262066 — Pleiades Device2026-10-30
K262276 — Cyperus2026-10-26
K262090 — Fertilis microICSI Device2026-10-09
K241626 — SperSort Sperm Sorting Chip (IPG02)2025-02-20
K241454 — Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)2025-02-03

More clearances from Fujifilm Irvine Scientific

view all

K250445 — Fast Warm - NX2025-09-12
K233764 — SSS-NX (Serum Substitute Supplement-NX)2024-04-24
K231804 — PRIME-XV FreezIS DMSO-Free MD2023-11-09

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