Kairison
KAIRISON Tubing Set pneumatic, (3000 mm), sterile, disposable, to be used with: FK898R, package of 10 pieces
7manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Zhejiang (3), Shanghai (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| Jinyuan Medical Equipment(Tianjin)Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 27 |
| Shanghai Foreign Trade Enterprises Pudong Co., Ltd. | Shanghai | Shanghai | Exporter | 12 |
| Wenzhou Ezekiel Creative Electronic Technology Co., Ltd. | Wenzhou | Zhejiang | Repacker / relabeller | 4 |
| Wenzhou Songling Healthcare Equipment Co., Ltd. | Wenzhou | Zhejiang | Manufacturer | 4 |
| Shanghai Bojin Electric Instrument & Device Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Ningbo Boly Medical Equipment Co., Ltd. | Yuyao | Zhejiang | Repacker / relabeller | 2 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | GET |
| Device type | Motor, Surgical Instrument, Pneumatic Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-07-26 |
| Record revised | 2021-06-08 (version 6) |
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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| FK888SU | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| De Soutter Medical | DE Soutter Medical Ltd. | 268 |
| Leopard | Imedicom Co., Ltd. | 15 |
| Ultrapower | ConMed Corporation | 14 |
| Conmed | ConMed Corporation | 7 |
| Leopard Micro | Imedicom Co., Ltd. | 6 |
| MicroAire® | Microaire Surgical Instruments LLC | 5 |
| Aesculap | Aesculap AG | 5 |
| HI-Line XS | Aesculap AG | 5 |
| Hall Osteon | ConMed Corporation | 4 |
| HI-Line | Aesculap AG | 3 |
| Endo Dissect | Covidien LP | 3 |
| Motor, Surgical Instrument, Pneumatic Powered | ConMed Corporation | 2 |
Showing 12 of 22. All products under Motor, Surgical Instrument, Pneumatic Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K960473 | 1996-03-07 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-12-09 | Class II | Device Design | Certain lots of the Aesculap Hi Line XXS handpiece (part # GB790R) were recalled due to a possible failure of the handpiece. | 14 | 2014-12-02 |
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.