Elan 4
HI-Line XS Diamond Burr Coarse II D1.0MM
7manufacturers in China registered for this device type
107catalogue numbers in this listing
1510(k) clearance
3recalls on this code
Who Else Makes It
Concentrated in Guangdong (5), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Shenzhen Jinlichang Electronic Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou | Guangdong | Manufacturer | 13 |
| Shenzhen Soga Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Ningbo Advan Electrical Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | GEY |
| Device type | Motor, Surgical Instrument, Ac-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 | 2020-10-27 |
| Record revised | 2023-08-25 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2023-02-23 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MD809 | 5 | In distribution | |
| GB698R | In distribution | ||
| MD745 | 5 | In distribution | |
| MD909 | 5 | In distribution | |
| MD740 | 5 | In distribution | |
| US648SU | In distribution | ||
| MD879 | 5 | In distribution | |
| US654SU | In distribution | ||
| US664SU | In distribution | ||
| US672SU | In distribution | ||
| US653SU | In distribution | ||
| MD865 | 5 | In distribution | |
| MD770 | 5 | In distribution | |
| US390SU | In distribution | ||
| MD743 | 5 | In distribution | |
| MD791 | 5 | In distribution | |
| US299SU | In distribution | ||
| MD789 | 5 | In distribution | |
| US229 | In distribution | ||
| US669SU | In distribution | ||
| MD775 | 5 | In distribution | |
| US077SU | In distribution | ||
| MD799 | 5 | In distribution | |
| US391SU | In distribution | ||
| MD751 | 5 | In distribution | |
| US667SU | In distribution | ||
| MD709 | 5 | In distribution | |
| US296SU | In distribution | ||
| MD798 | 5 | In distribution | |
| MD747 | 5 | In distribution | |
| US264SU | In distribution | ||
| MD702 | 5 | In distribution | |
| MD802 | 5 | In distribution | |
| MD780 | 5 | In distribution | |
| US670SU | In distribution | ||
| US647SU | In distribution | ||
| US292SU | In distribution | ||
| US265SU | In distribution | ||
| US076SU | In distribution | ||
| US656SU | In distribution | ||
| MD742 | 5 | In distribution | |
| US394TC-SU | In distribution | ||
| US082SU | In distribution | ||
| MD757 | 5 | In distribution | |
| US083SU | In distribution | ||
| US223 | In distribution | ||
| US644SU | In distribution | ||
| GB691R | In distribution | ||
| MD807 | 5 | In distribution | |
| MD771 | 5 | In distribution | |
| MD708 | 5 | In distribution | |
| US298SU | In distribution | ||
| MD870 | 5 | In distribution | |
| US673SU | In distribution | ||
| MD707 | 5 | In distribution | |
| US645SU | In distribution | ||
| GB692R | In distribution | ||
| US262SU | In distribution | ||
| US651SU | In distribution | ||
| US227 | In distribution | ||
| MD769 | 5 | In distribution | |
| MD806 | 5 | In distribution | |
| MD754 | 5 | In distribution | |
| US261SU | In distribution | ||
| GP396TC | In distribution | ||
| US221 | In distribution | ||
| US293SU | In distribution | ||
| US038SU | In distribution | ||
| US295SU | In distribution | ||
| GB679R | In distribution | ||
| MD703 | 5 | In distribution | |
| MD756 | 5 | In distribution | |
| US079SU | In distribution | ||
| MD755 | 5 | In distribution | |
| US074SU | In distribution | ||
| US663SU | In distribution | ||
| MD705 | 5 | In distribution | |
| US666SU | In distribution | ||
| MD746 | 5 | In distribution | |
| GB697R | In distribution | ||
| US394SU | In distribution | ||
| US650SU | In distribution | ||
| US073SU | In distribution | ||
| MD711 | 5 | In distribution | |
| US080SU | In distribution | ||
| MD718 | 5 | In distribution | |
| US393TC-SU | Withdrawn | ||
| MC191 | Withdrawn | ||
| US210 | Withdrawn | ||
| MD762 | 5 | Withdrawn | |
| MC036 | Withdrawn | ||
| MC190 | Withdrawn | ||
| US232 | Withdrawn | ||
| US233 | Withdrawn | ||
| MC173 | Withdrawn | ||
| MC017 | Withdrawn | ||
| MC170 | Withdrawn | ||
| MC267 | Withdrawn | ||
| US209 | Withdrawn | ||
| US231 | Withdrawn | ||
| US393SU | Withdrawn | ||
| US208 | Withdrawn | ||
| US207 | Withdrawn | ||
| MC037 | Withdrawn | ||
| MC169 | Withdrawn | ||
| MD749 | 5 | Withdrawn | |
| MC143 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| De Soutter Medical | DE Soutter Medical Ltd. | 1,481 |
| HI-Line XS | Aesculap AG | 169 |
| Zaguar | Imedicom Co., Ltd. | 131 |
| Aesculap | Aesculap AG | 72 |
| HI-Line | Aesculap AG | 53 |
| Motor, Surgical Instrument, Ac-Powered | Anspach Effort, The | 37 |
| Zimmer Biomet™ | Zimmer Surgical, Inc. | 29 |
| Motor, Surgical Instrument, Ac-Powered | Synthes Gmbh | 29 |
| HI-Line XXS | Aesculap AG | 22 |
| Motor, Surgical Instrument, Ac-Powered | Smith & Nephew, Inc. | 20 |
| Eccos | Aesculap AG | 11 |
| Motor, Surgical Instrument, Ac-Powered | Richard Wolf Gmbh | 10 |
Showing 12 of 149. All products under Motor, Surgical Instrument, Ac-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K913262 | 1991-12-30 |
Recalls
3 of these are 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 |
|---|---|---|---|---|---|
| 2017-03-28 | Class II | Process control | Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. These particulates could also lead to mechanically | total amount of burrs – 608 | 2018-02-06 |
| 2017-03-28 | Class II | Process control | Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. These particulates could also lead to mechanically | total of all burrs 608 units | 2018-02-06 |
| 2017-03-28 | Class II | Process control | Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. These particulates could also lead to mechanically | Total of all burrs – 608 units | 2018-02-06 |
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.