Cook
MINC+ Benchtop Incubator
4manufacturers in China registered for this device type
5catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (2), Hubei (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Saint-Gobain Life Sciences (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 5 |
| Wuhan Huchuang Union Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 8 |
| HUA YUE Medical Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 7 |
| CGN Gray (Shenzhen) Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
Record
| Listed by | William A. Cook Australia PTY, Ltd., Australia |
|---|---|
| FDA product code | MQG |
| Device type | Accessory, Assisted Reproduction |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6120 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K983642 |
| Record published | 2016-09-24 |
| Record revised | 2023-08-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Special storage condition: Store in dark, dry, cool place |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G20079 | In distribution | |
| G51607 | In distribution | |
| G18226 | In distribution | |
| G49275 | In distribution | |
| G44429 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Coda® | LifeGlobal Group, LLC | 42 |
| Thermo Scientific Forma | Thermo Fisher Scientific (Asheville) LLC | 22 |
| Rocket | Rocket Medical PLC | 6 |
| Kryo ART Freezer | Planer Limited | 6 |
| Panasonic | PHC Corporation | 6 |
| Metiec | Wuhan Huchuang Union Technology Co., Ltd. | 3 |
| BT37 Incubator | Planer Limited | 3 |
| RI Witness | Research Instruments Ltd | 3 |
| Thermo Scientific | Thermo Electron LED GmbH | 2 |
| Multiroom IVF incubator | Esco Medical Technologies, UAB | 2 |
| Kryo 360 Freezer | Planer Limited | 2 |
| PHCbi | PHC Corporation | 2 |
Showing 12 of 41. All products under Accessory, Assisted Reproduction
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160753 | 2017-06-13 |
Recalls Naming This Product
6 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Cook Incorporated | UDI-DI | 2023-12-07 | Class II | Device Design | The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static electricity) is applied to the lid of the device. This may lead to embryo degeneration necessitating an additional medical procedure for the pa | 14 US; 101 OUS | |
| Cook Incorporated | 510(k) number | 2020-12-16 | Class II | Under Investigation by firm | A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that can cause the silicone stoppers to dislodge or gas to leak from the flasks, impeding gas flow to the incubation chambers of the Mini Incubator. | 56250 | 2023-11-08 |
| Cook Incorporated | 510(k) number | 2018-03-22 | Class II | Nonconforming Material/Component | Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to the user. | 132 | 2020-05-13 |
| Cook Incorporated | 510(k) number | 2018-03-22 | Class II | Nonconforming Material/Component | Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to the user. | 2,267 | 2020-05-13 |
| Cook Incorporated | 510(k) number | 2018-01-12 | Class II | Device Design | The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failure of the flat flex lid heater. | 483 | 2020-05-08 |
| Cook Incorporated | 510(k) number | 2018-01-12 | Class II | Device Design | The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failure of the flat flex lid heater. | 4,451 | 2020-05-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.