510(k) K161261
- Device
- Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase
- Applicant
- Genea Biomedx Pty Ltd
- 510(k) number
- K161261
- Product code
- MQL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-05-12
- Date received
- 2016-05-04
- Regulation
- 884.6180
- Classification name
- Media, Reproductive
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kea Dent
- Address
- Level 2, 321 Kent St. Sydney AU 2000 2000
FDA Registration Numbers#
- 1222779
- 3010413864
- 3036725842
- 3014755376
- 3015140190
- 3036495174
- 3007800906
- 9616005
- 3018010054
- 3021166069
- 3004882774
- 1216677
- 3016126174
- 3004048494
- 3003272500
- 3030681110
- 3025773437
- 3012853704
- 1221433
- 2031824
- 3014295858
- 3003274090
- 3003995932
- 3017896194
- 3005580113
- 3008876063
- 2022379
- 3030390242
- 3003766921
- 3033813683
- 3007738736
Source Documents#
Other 510(k) Records For Product Code MQL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260248 | Ultra-Fast Warm | Kitazato Corporation | 2026-04-28 |
| K252672 | CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5) | Casebioscience, Inc. | 2026-02-20 |
| K250445 | Fast Warm - NX | Fujifilm Irvine Scientific | 2025-09-12 |
| K251637 | Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 2025-08-27 |
| K251305 | Ultra-Fast Vitri; Ultra-Fast Warm | Kitazato Corporation | 2025-08-26 |
| K242640 | FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin | Fertipro NV | 2025-05-30 |
| K242561 | Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 2025-04-10 |
| K242089 | Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) | Jiangsu Ruifuda Medical Device Co., Ltd. | 2025-04-10 |
| K242107 | CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) | Casebioscience, Inc. | 2025-03-21 |
| K241833 | V-GRAD | Vitromed GmbH | 2025-03-21 |
| K242043 | Sperm Freezing Medium | Gimbo Medical Technology Shenzhen Co., Ltd. | 2025-01-08 |
| K241132 | ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) | Artsmedia Denmark Aps | 2024-12-18 |
| K241095 | ARTSMedia Semen Wash Medium | Artsmedia Denmark Aps | 2024-12-18 |
| K242968 | Giftlife® Single-Step Medium Plus | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-11-22 |
| K240176 | V-VITFREEZE and V-VITWARM | Vitromed GmbH | 2024-09-13 |
Legacy Summary#
summary
FDA Review#
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