Bioteque America, Inc.
Preferred Curette Sureflex
4manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | Bioteque America, Inc., United States |
|---|---|
| FDA product code | HHK |
| Device type | Curette, Suction, Endometrial (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1175 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K020628 |
| Record published | 2025-05-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BA8200 | 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)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K020628 | 2002-05-24 |
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.