Panels › Obstetrics/Gynecology › Product code MQG · Class 2
Accessory, Assisted Reproduction
Regulation 884.6120
2510(k)s in 12 months (47 all time)
0recalls in 12 months (9 all time)
8recalls that name a 510(k)
Top companies in MQG
| Company | 510(k)s | Recalls |
|---|---|---|
| Zander Medical Supplies, Inc. | 5 | 0 |
| Cook Inc. | 0 | 4 |
| CooperSurgical, Inc. | 1 | 3 |
| Unisense Fertilitech A/S | 4 | 0 |
| Genea Biomedx Pty, Ltd. | 3 | 0 |
| <Genx> Intl., Inc. | 3 | 0 |
| At Medical Uab | 2 | 0 |
| Cook Medical Llc | 0 | 2 |
| Cook Ob/Gyn | 2 | 0 |
| Cook Urological, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 12, 2024 | Cook Medical Llc MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429 Open, Classified |
MQG | None listed |
| Sep 28, 2022 | CooperSurgical, Inc. Humidifier bottle and syringe filter kit (6 count of each) for the BT37
Mark II Benchtop Incubator (AY200246) Open, Classified |
MQG | K121566 |
| Sep 28, 2022 | CooperSurgical, Inc. Humidifier bottle and syringe filter kit (6 count of each) for the BT37
Mark I Benchtop Incubator (AY102295).
The Mark I model is no longer produced, but the legacy humidifier
bottle component design Open, Classified |
MQG | K121566 |
| Dec 16, 2020 | Cook Medical Llc Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707 Terminated |
MQG | K983642 |
| Sep 5, 2019 | CooperSurgical, Inc. Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activit Terminated |
MQG | K160504 |
| Apr 13, 2018 | Cook Inc. MINC Benchtop Incubator (Mini Incubator)
catalog (K-MINC-1000) G20079 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture. Terminated |
MQG | K983642 |
| Apr 13, 2018 | Cook Inc. MINC Benchtop Incubator (Mini Incubator)
catalog (K-MINC-1000 US) G46022 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture. Terminated |
MQG | K983642 |
| Mar 22, 2018 | Cook Inc. Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275.
Intended for the aspiration of body fluids and cells, in particular oocyte aspiration. Terminated |
MQG | K160753 K992070 |
| Mar 22, 2018 | Cook Inc. Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607.
Intended for the aspiration of body fluids and cells; in particular oocyte aspiration. Terminated |
MQG | K992070 |
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