USA Elite
USA Elite System and USA Series Ellik Evacuator Adapter, Non-Locking
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Peter’s Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Ucomfor Medical Co., Ltd. | Shanghai | Shanghai | Exporter | 17 |
| Shenzhen Trious Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Record
| Listed by | Gyrus Acmi, Inc., United States |
|---|---|
| FDA product code | KQT |
| Device type | Evacuator, Gastro-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4370 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-10-11 |
| Record revised | 2024-09-02 (version 4) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 191-NRS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Evacuator, Gastro-Urology | Stryker GmbH | 34 |
| BioVac | Us Endoscopy | 7 |
| Evacuator, Gastro-Urology | Richard Wolf Gmbh | 3 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 3 |
| Toomey | Gyrus Acmi, Inc. | 2 |
| Cook CollectEVAC | Civco Medical Instruments Co., Inc. | 2 |
| Trious | Shenzhen Trious Medical Technology Co., Ltd. | 2 |
| AED | National Advanced Endoscopy Devices, Inc. | 2 |
| Occlusion Disc | GRI Medical Products, Inc. | 1 |
| Intussusception Air Reduction Kit with Pink Tip | GRI Medical Products, Inc. | 1 |
| Intussusception Air Reduction Bulb & Gauge | GRI Medical Products, Inc. | 1 |
| Ahto | Stryker GmbH | 1 |
Showing 12 of 29. All products under Evacuator, Gastro-Urology
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| 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). | 2 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.