Aesculap
Angled hose adaptor
7manufacturers in China registered for this device type
5catalogue numbers in this listing
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 | 2020-04-23 |
| Record revised | 2022-07-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2021-04-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GA513R | In distribution | |
| GA508R | In distribution | |
| GA506R | Withdrawn | |
| GA505R | Withdrawn | |
| GA523R | Withdrawn |
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 |
| 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 |
| The Woodpecker | IMT Integral Medizintechnik AG | 1 |
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.