Olympus
Versapoint Bipolar Electrode - Twizzle Tip 5 Fr. (1.6 mm nom.) x 360 mm
13manufacturers in China registered for this device type
57catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (4), Guangdong (4), Jiangsu (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Peter’s Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Qingdao O-MEC Medical Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 6 |
| Ningbo Skonsin Electronics Ltd. | Ningbo | Zhejiang | Contract manufacturer | 1 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Zhejiang Huanyi Sterilization Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 25 |
| Macrolux Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Guangzhou RED Pine Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 8 |
| Shanghai AnQing Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 5 |
| Guangdong EO Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 5 |
| Suzhou Acuvu Medical Technology Co., Ltd. | Suzhou | Jiangsu | Specification developer | 4 |
| Jiangsu Jiyuan Medical Technology Co., Ltd. | Taizhou | Jiangsu | Specification developer | 3 |
Showing 12 of 13. All 13 manufacturers in China registered for Hysteroscope (And Accessories)
Record
| Listed by | Olympus Winter & IBE Gmbh, Germany |
|---|---|
| FDA product code | HIH |
| Device type | Hysteroscope (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1690 |
| Establishment | Contract manufacturer, Specification developer, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K897003 |
| Record published | 2016-09-21 |
| Record revised | 2025-10-31 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2024-06-21 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| WA47788A | 5 | In distribution | |
| WA20021A | In distribution | ||
| WA2T470A | In distribution | ||
| A42021A | In distribution | ||
| A22002A | In distribution | ||
| WA47784A | In distribution | ||
| A4672A | In distribution | ||
| A42071A | In distribution | ||
| A22266C | 12 | In distribution | |
| WA20023A | In distribution | ||
| A0205 | 10 | In distribution | |
| A4767 | In distribution | ||
| WA47777A | In distribution | ||
| WA47560S | 5 | In distribution | |
| WA2T43WA | In distribution | ||
| WA47551S | 5 | In distribution | |
| WA47505S | 5 | In distribution | |
| WA2T430A | In distribution | ||
| WA47507S | 5 | In distribution | |
| WA2T400A | In distribution | ||
| A44728C | 12 | In distribution | |
| WA47782A | 5 | In distribution | |
| WA47783A | 5 | In distribution | |
| A4770 | In distribution | ||
| A0464 | In distribution | ||
| WA2T412A | In distribution | ||
| A4760 | In distribution | ||
| A22258A | Withdrawn | ||
| A22250A | Withdrawn | ||
| A22004A | Withdrawn | ||
| A4766 | Withdrawn | ||
| A3066 | Withdrawn | ||
| A22259A | Withdrawn | ||
| A22255A | Withdrawn | ||
| A22231B | Withdrawn | ||
| A22211A | Withdrawn | ||
| A22001A | Withdrawn | ||
| A22207A | Withdrawn | ||
| A4764 | Withdrawn | ||
| A22202A | Withdrawn | ||
| A22251A | Withdrawn | ||
| A4763 | Withdrawn | ||
| A22205B | Withdrawn | ||
| A4742 | Withdrawn | ||
| A4744 | Withdrawn | ||
| A4740 | Withdrawn | ||
| A4211A | Withdrawn | ||
| A22205A | Withdrawn | ||
| A3040 | Withdrawn | ||
| A22206A | Withdrawn | ||
| A22253A | Withdrawn | ||
| A22203A | Withdrawn | ||
| A22003A | Withdrawn | ||
| A22005A | Withdrawn | ||
| WA2P400A | Withdrawn | ||
| A22000A | Withdrawn | ||
| A4741 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hysteroscope (And Accessories) | Karl Storz GmbH & Co. KG | 255 |
| AED | National Advanced Endoscopy Devices, Inc. | 79 |
| USA Elite | Gyrus Acmi, Inc. | 79 |
| Hysteroscope (And Accessories) | Stryker GmbH | 42 |
| TruClear | Covidien LP | 29 |
| Hysteroscopy sheath | Sopro-Comeg GmbH | 28 |
| Hysteroscope (And Accessories) | Richard Wolf Gmbh | 24 |
| Hysteroscope | Sopro-Comeg GmbH | 18 |
| Elite 2 System | Gyrus Acmi, Inc. | 17 |
| Gynecare Versapoint | Ethicon, Inc. | 16 |
| USA Elite System | Gyrus Acmi, Inc. | 11 |
| SlimLine | Gyrus Acmi, Inc. | 10 |
Showing 12 of 177. All products under Hysteroscope (And Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213207 | 2021-12-22 |
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|
| Olympus Corporation of the Americas | UDI-DI | 2025-11-11 | Class II | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. | 91 units |
| Olympus Corporation of the Americas | 510(k) number | 2024-04-18 | Class II | Process change control | The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image. | 1 unit |
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.