USA Elite
USA Elite System Cystourethroscope Albarran Deflecting Bridge, Double-Horn 23-25 Fr, (7.7-8.3 mm) CC Yellow/Green
13manufacturers in China registered for this device type
79catalogue 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 | Gyrus Acmi, Inc., United States |
|---|---|
| FDA product code | HIH |
| Device type | Hysteroscope (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1690 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K890328 |
| Record published | 2016-10-05 |
| Record revised | 2024-09-02 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| REXESRS-24 | In distribution | |
| CFR | In distribution | |
| CLO-23 | In distribution | |
| EIS-HCF27 | In distribution | |
| ESRS-28 | In distribution | |
| E159 | In distribution | |
| CLB8-23 | In distribution | |
| CLB8-23SB | In distribution | |
| ETA-NL | In distribution | |
| ETOR-28 | In distribution | |
| EIWE-S | In distribution | |
| ETA-LCF | In distribution | |
| E117-O | In distribution | |
| EIS-HCF25 | In distribution | |
| ETO-CFR-25 | In distribution | |
| ERVO-CF27 | In distribution | |
| EVOR-24 | In distribution | |
| REXEIS-HCF25 | In distribution | |
| E154 | In distribution | |
| REXEIS-CFR-27 | In distribution | |
| CLV-23 | In distribution | |
| REXEIS-CFR-25 | In distribution | |
| EMRS-26 | In distribution | |
| E117-S | In distribution | |
| E121-O | In distribution | |
| E152 | In distribution | |
| REXESRS-28 | In distribution | |
| ETO-CFR-27 | In distribution | |
| EVO-CFR-25 | In distribution | |
| ETOR-26 | In distribution | |
| EMRS-24 | In distribution | |
| E164 | In distribution | |
| ERTO-CF27 | In distribution | |
| CLS-23SB | In distribution | |
| ETOR-24B | In distribution | |
| REXERIS-CF27 | In distribution | |
| ETOR-24 | In distribution | |
| EVO-CFR-27 | In distribution | |
| E151 | In distribution | |
| CLS-23 | In distribution | |
| E125-S | In distribution | |
| EMWE | In distribution | |
| E161 | In distribution | |
| E158 | In distribution | |
| ESRS-26 | In distribution | |
| E125-O | In distribution | |
| EMRS-26B | In distribution | |
| EMRS-28B | In distribution | |
| ETOR-28B | In distribution | |
| E153 | In distribution | |
| E165 | In distribution | |
| E157 | In distribution | |
| REXEMRS-26 | In distribution | |
| ESRS-24 | In distribution | |
| E123-O | In distribution | |
| E123-S | In distribution | |
| REXEMRS-28 | In distribution | |
| EBRS-26 | In distribution | |
| ETA-L | In distribution | |
| GYNE-BR | In distribution | |
| EIWE-A | In distribution | |
| REXEIS-HCF27 | In distribution | |
| E163 | In distribution | |
| E155 | In distribution | |
| EIS-CFR-27 | In distribution | |
| EMRS-28 | In distribution | |
| ETOR-26B | In distribution | |
| EBWE | In distribution | |
| E121-S | In distribution | |
| EOS-CFR-27 | In distribution | |
| REXM3-110A | In distribution | |
| ERVO-CF25 | In distribution | |
| REXEMRS-24 | In distribution | |
| REXESRS-26 | In distribution | |
| EBRS-28 | In distribution | |
| ERTO-CF25 | In distribution | |
| 190-NRS | In distribution | |
| EMRS-24B | In distribution | |
| EVOR-28 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hysteroscope (And Accessories) | Karl Storz GmbH & Co. KG | 255 |
| AED | National Advanced Endoscopy Devices, Inc. | 79 |
| Olympus | Olympus Winter & IBE Gmbh | 57 |
| 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 |
|---|---|
| K092278 | 2009-09-29 |
Recalls Naming This Product
3 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 | 510(k) number | 2025-06-18 | Class II | Packaging change control | Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU). | 19 units |
| Olympus Corporation of the Americas | 510(k) number | 2025-06-18 | Class II | Packaging change control | Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU). | 41 units |
| Olympus Corporation of the Americas | UDI-DI | 2025-06-18 | Class II | Packaging change control | Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU). | 5 units |
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.