SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT— 510(k) K152782

Name: FDA 510(k) clearance K152782
Creator: U.S. Food and Drug Administration
Published: 2015-12-21

Substantially Equivalent

William A. Cook Australia Pty. , Ltd.

FDA 510(k) clearance K152782 for SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT, Substantially Equivalent on 2015-12-21. Applicant: William A. Cook Australia Pty. , Ltd.. Device class: 2.

Clearance details

Applicant: William A. Cook Australia Pty. , Ltd.
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2015-09-25
Decision date: 2015-12-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Eight Mile Plains, AU

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 William A. Cook Australia Pty. , Ltd.

view all

K173431 — Towako Transmyometrial Embryo Transfer Set2018-05-18
K171611 — Double Lumen Ovum Aspiration Needles2017-12-15
K160753 — COOK Vacuum Pump2017-06-13
K170257 — Sydney IVF Culture Oil2017-02-24
K153478 — Sydney IVF Gamete Buffer2016-08-15

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