Versajet III Hydrosurgery System Console
The VERSAJET III console powers and controls a hydrosurgery system for wound and soft tissue debridement. With a compatible sterile handpiece, the system uses a pressurized stream of saline…
The VERSAJET III console powers and controls a hydrosurgery system for wound and soft tissue debridement. With a compatible sterile handpiece, the system uses a pressurized stream of saline to cut, ablate and remove tissue and foreign material.
The reusable, mains powered console provides a touchscreen for selecting pressure settings. A foot pedal offers another control route, with ten factory preset levels that increase the delivered pressure as the setting rises.
Fluid and Debris Path
At the treatment site, saline removes material tangentially from the tissue surface. The handpiece collects the excised tissue and fluid and carries them through flexible tubing to a drain or collection canister. Indications include acute or chronic wounds, burns and surgical site cleansing where sharp debridement is required.
Who Else Makes It
Concentrated in Guangdong (7), Beijing (4), Jiangsu (3). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Elite Medtek(Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
| Dongguan Kaiser Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 7 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Dongguan Hong De Medical Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng | Beijing | Manufacturer | 25 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Anqing Changfan Medical Instrument Co., Ltd. | Anqing | Anhui | Manufacturer | 9 |
| Shenzhen Relish Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 9 |
Showing 12 of 17. All 17 manufacturers in China registered for Lavage, Jet
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | FQH |
| Device type | Lavage, Jet |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5475 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K220964 |
| Record published | 2023-05-31 |
| Record revised | 2023-09-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -20 to 55 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 66802146 | 498x600x282 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| De Soutter Medical | DE Soutter Medical Ltd. | 65 |
| InterPulse | Stryker GmbH | 41 |
| Lavage, Jet | Stryker GmbH | 40 |
| Pulsavac® | Zimmer Orthopaedic Surgical Products | 35 |
| MicroAire® | Microaire Surgical Instruments LLC | 34 |
| Cleanest | Guangzhou Clean Medical Products Manufacturing Corp | 32 |
| Simpulse | Davol Inc. | 31 |
| AWI | Apex (Suzhou) Medical Products Company | 27 |
| CarboJet® CO2 Bone Lavage System | Kinamed, Inc. | 26 |
| Zksk | Beijing Zksk Technology Co., Ltd. | 20 |
| Erbe | Erbe Elektromedizin GmbH | 18 |
| AWI | Apex (Guangzhou) Tools & Orthopedics Company | 18 |
Showing 12 of 98. All products under Lavage, Jet
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220964 | 2023-05-16 |
| K143115 | 2015-07-15 |
| K110958 | 2011-08-01 |
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.