StrykeFlow
Disposable Suction / Irrigation Tip, Standard, Vented, Metal Finish
30manufacturers in China registered for this device type
2catalogue numbers in this listing
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) | K954726 |
| Record published | 2016-09-23 |
| Record revised | 2026-02-25 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 6 |
| Sizes | Length 32 cm; outer diameter 5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0250070520 | In distribution | |
| 0250070505 | Length 32.0 cm | 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
22 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 | Closed |
|---|---|---|---|---|---|---|---|
| Stryker Endoscopy | 510(k) number | 2025-06-18 | Class II | Under Investigation by firm | Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction. | ||
| Stryker Endoscopy | UDI-DI | 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 | 2013-03-27 | Class II | Error in labeling | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C. | 147,921 – all sizes | 2013-09-24 |
| Stryker Endoscopy | 510(k) number | 2013-03-27 | Class II | Error in labeling | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C. | 147,921 – all sizes | 2013-09-24 |
| Stryker Endoscopy | 510(k) number | 2013-03-27 | Class II | Error in labeling | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C. | 147,921 – all sizes | 2013-09-24 |
| Stryker Endoscopy | 510(k) number | 2013-03-27 | Class II | Error in labeling | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C. | 147,921 – all sizes | 2013-09-24 |
| Stryker Endoscopy | 510(k) number | 2013-03-27 | Class II | Error in labeling | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C. | 147,921 – all sizes | 2013-09-24 |
| Stryker Endoscopy | 510(k) number | 2013-03-27 | Class II | Error in labeling | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C. | 147,921 – all sizes | 2013-09-24 |
| Stryker Endoscopy | 510(k) number | 2013-03-27 | Class II | Error in labeling | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C. | 147,921 – all sizes | 2013-09-24 |
| Stryker Endoscopy | 510(k) number | 2013-03-27 | Class II | Error in labeling | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C. | 147,921 – all sizes | 2013-09-24 |
| Stryker Endoscopy | 510(k) number | 2013-03-27 | Class II | Error in labeling | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C. | 147,921 – all sizes | 2013-09-24 |
| Stryker Endoscopy | 510(k) number | 2013-03-27 | Class II | Error in labeling | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C. | 147,921 – all sizes | 2013-09-24 |
| Stryker Endoscopy | 510(k) number | 2013-03-27 | Class II | Error in labeling | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C. | 147,921 – all sizes | 2013-09-24 |
| Stryker Endoscopy | 510(k) number | 2013-03-27 | Class II | Error in labeling | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C. | 147,921 – all sizes | 2013-09-24 |
| Stryker Endoscopy | 510(k) number | 2013-03-27 | Class II | Error in labeling | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C. | 147,921 – all sizes | 2013-09-24 |
| Stryker Endoscopy | 510(k) number | 2013-03-27 | Class II | Error in labeling | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C. | 147,921 – all sizes | 2013-09-24 |
| Stryker Endoscopy | 510(k) number | 2013-03-27 | Class II | Error in labeling | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C. | 147,921 – all sizes | 2013-09-24 |
| Stryker Endoscopy | 510(k) number | 2013-03-27 | Class II | Error in labeling | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C. | 147,921 – all sizes | 2013-09-24 |
| Stryker Endoscopy | 510(k) number | 2013-03-27 | Class II | Error in labeling | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C. | 147,921 – all sizes | 2013-09-24 |
| Stryker Endoscopy | 510(k) number | 2013-03-27 | Class II | Error in labeling | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C. | 147,921 – all sizes | 2013-09-24 |
| Stryker Endoscopy | 510(k) number | 2013-03-27 | Class II | Error in labeling | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C. | 147,921 – all sizes | 2013-09-24 |
| Stryker Endoscopy | 510(k) number | 2013-03-27 | Class II | Error in labeling | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C. | 147,921 – all sizes | 2013-09-24 |
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.