SPERM CRYOPROTEC— 510(k) K023206

Substantially Equivalent

Nidacon International AB

FDA 510(k) clearance K023206 for SPERM CRYOPROTEC, Substantially Equivalent on 2002-11-08. Applicant: Nidacon International AB. Device class: 2.

Clearance details

Applicant: Nidacon International AB
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2002-09-25
Decision date: 2002-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, US

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 Nidacon International AB

K131145 — PROINSERT2014-02-20
K092107 — VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-0102010-06-15
K022443 — SPERMASSIST2002-08-28
K011607 — SPERMCATCH2001-08-10
K012123 — NIDOIL2001-08-03

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