SpermSelect Mini Kit
Contents: one SpermSelect System and one MiniSpace
4manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Shuyou Surgical Instrument Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Jiangsu Suyun Medical Materials Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 11 |
| Yangzhong Meidi Medical Products Co., Ltd. | Yangzhong | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Coopersurgical, Inc., United States |
|---|---|
| FDA product code | HHK |
| Device type | Curette, Suction, Endometrial (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1175 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K974819 |
| Record published | 2016-08-09 |
| Record revised | 2024-02-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SM601-F | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cannula-Curette | Coopersurgical, Inc. | 25 |
| Berkeley Vacurette | Gyrus Acmi, Inc. | 22 |
| Rigid Uterine Aspiration Curette | Gcmedica Enterprise Ltd.(Wuxi) | 18 |
| Tis-U-Trap Uterine Suction Curette Set | Coopersurgical, Inc. | 17 |
| Cannula-Curette with 60cc Handyvak Syringe | Coopersurgical, Inc. | 11 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 7 |
| Curette, Suction, Endometrial (And Accessories) | Panpac Medical Corporation | 6 |
| Bioteque | Bioteque Taiwan Ltd. | 5 |
| Flexible Uterine Aspiration Curette | Gcmedica Enterprise Ltd.(Wuxi) | 5 |
| Suresample, Endometrial Sampler | Gynex Corporation | 4 |
| Pioneer IVF® | LifeGlobal Group, LLC | 4 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 3 |
Showing 12 of 43. All products under Curette, Suction, Endometrial (And Accessories)
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-10-27 | Class III | Packaging process control | The product has been identified to contain an incorrect curette type. | 30 | 2015-05-28 |
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.