Disposa-TOP
DISPOSA-TOP, W/GAUZE SAC & O-RING For glass bottles & 1/2" (13mm) tubing (10/PK)
4manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Gyrus Acmi, 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, Exporter |
| 510(k) | K875084 |
| Record published | 2016-10-12 |
| Record revised | 2024-09-02 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 54912 | In distribution | |
| 56134-2 | 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)
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.