Ahto
Irrigation Pump
30manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (8), Jiangsu (7), Guangdong (7). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Dongguan Junhai Medical Device Co., Ltd. | Dong Guang | Guangdong | Contract manufacturer | 9 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Rusun Medical Co., Ltd. | Yichun | Jiangxi | Manufacturer | 37 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Tianjin Tairuibosi Medical Appliance Co., Ltd. | Tianjin | Tianjin | Private-label distributor | 30 |
Showing 12 of 30. All 30 manufacturers in China registered for Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | GCX |
| Device type | Apparatus, Suction, Operating-Room, Wall Vacuum Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6740 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K042454 |
| Record published | 2016-08-22 |
| Record revised | 2021-10-14 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0250070601 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vacutron | Allied Medical LLC | 764 |
| Cardinal Health | Cardinal Health 200, LLC | 310 |
| Aesculap | Aesculap AG | 243 |
| Single Use Professional | Eakin Surgical Ltd | 168 |
| Medi-VAC | Cardinal Health 200, LLC | 158 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 121 |
| Du-O-Vac | W.T. Farley, Inc. | 91 |
| Ambler Surgical | Ambler Surgical, LLC | 66 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | Biomet Microfixation | 65 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 44 |
| OMT LLC | OMT, LLC | 39 |
| Argyle | Cardinal Health | 38 |
Showing 12 of 257. All products under Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Stryker Endoscopy | 510(k) number | 2026-06-08 | Class II | Under Investigation by firm | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. | 46,212 units | |
| Stryker Endoscopy | 510(k) number | 2026-06-08 | Class II | Under Investigation by firm | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. | 41,052 units | |
| Stryker Endoscopy | 510(k) number | 2026-06-08 | Class II | Under Investigation by firm | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. | 2,739 of units | |
| Stryker Endoscopy | 510(k) number | 2017-11-17 | Class II | Under Investigation by firm | Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. | 60,753 units total | 2024-01-29 |
| Stryker Endoscopy | 510(k) number | 2005-11-18 | Not classified | Other | Devices for which sterility may be compromised as evidenced by a crack in the package. | 48405 boxes, 6 units per box | 2006-11-02 |
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.