Cook Sydney Ivf Blastocyst Vitrification (K-SIBV-5000), Warming (K-SIBW-5000) Kits
FDA 510(k) K082363 · William A. Cook Australia Pty. , Ltd.
510(k) numberK082363
Submission
- Device name
- Cook Sydney Ivf Blastocyst Vitrification (K-SIBV-5000), Warming (K-SIBW-5000) Kits
- Applicant
- William A. Cook Australia Pty. , Ltd.
Eight Mile Plains, Qld, AU - Received
- August 18, 2008
- Decision date
- April 29, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQL – Media, Reproductive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6180
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code MQL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254261 | Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)MQL · Traditional | Cell Store (Beijing) Biotechnology Co., Ltd. | 08/28/2026SE |
| K260248 | Ultra-Fast WarmMQL · Traditional | Kitazato Corporation | 04/28/2026SE |
| K252672 | CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)MQL · Traditional | Casebioscience, Inc. | 02/20/2026SE |
| K250445 | Fast Warm - NXMQL · Traditional | Fujifilm Irvine Scientific | 09/12/2025SE |
| K251637 | Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle…MQL · Traditional | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 08/27/2025SE |
| K251305 | Ultra-Fast Vitri; Ultra-Fast WarmMQL · Traditional | Kitazato Corporation | 08/26/2025SE |
| K242640 | FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicinMQL · Traditional | Fertipro NV | 05/30/2025SE |
| K242561 | Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)MQL · Traditional | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 04/10/2025SE |
| K242089 | Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)MQL · Traditional | Jiangsu Ruifuda Medical Device Co., Ltd. | 04/10/2025SE |
| K242107 | CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC)…MQL · Traditional | Casebioscience, Inc. | 03/21/2025SE |
More from Casebioscience, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K173431 | Towako Transmyometrial Embryo Transfer SetMQF · Special | 05/18/2018SE |
| K171611 | Double Lumen Ovum Aspiration NeedlesMQE · Special | 12/15/2017SE |
| K160753 | COOK Vacuum PumpMQG · Traditional | 06/13/2017SE |
| K170257 | Sydney IVF Culture OilMQL · Special | 02/24/2017SE |
| K153478 | Sydney IVF Gamete BufferMQL · Traditional | 08/15/2016SE |
| K152717 | Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing KitMQL · Special | 05/06/2016SE |
| K160814 | Sydney IVF Sperm Cryopreservation BufferMQL · Special | 04/22/2016SE |
| K153290 | Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage…MQL · Special | 01/27/2016SE |
| K151367 | Sydney IVF HyaluronidaseMQL · Traditional | 01/27/2016SE |
| K152782 | Sydney Ivf Sperm Medium, Sydney Ivf Sperm Gradient Kit, Sydney Ivf SpermientMQL · Special | 12/21/2015SE |
Questions and answers
When was Cook Sydney Ivf Blastocyst Vitrification (K-SIBV-5000), Warming (K-SIBW-5000) Kits cleared by the FDA?
Cook Sydney Ivf Blastocyst Vitrification (K-SIBV-5000), Warming (K-SIBW-5000) Kits (K082363) received a 510(k) decision of Substantially Equivalent on April 29, 2009, 254 days after the submission was received.
What is the product code of K082363?
The FDA product code is MQL – Media, Reproductive, a Class II (moderate risk) device regulated under 21 CFR 884.6180.