Gyrus Acmi
Tubing With Male Connector For 194 Ellik Evacuator
5manufacturers in China registered for this device type
3catalogue numbers in this listing
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 |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 194-2 | In distribution | |
| 190-4 | In distribution | |
| 190A | 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 |
| 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 |
| USA Elite | Gyrus Acmi, 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
4 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Olympus Corporation of the Americas | UDI-DI | 2026-05-05 | Class II | Under Investigation by firm | Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices. | 3,663 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). | 16 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). | 1 unit |
| 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). | 48 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.