Lighted WaveCurette™
Catalogue number 2230, listed by Bionix, LLC, United States, under Curette, Ear. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (2), Guangdong (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Jiangsu Huadong Medical Device Industry Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 29 |
| Shenzhen Heearly Technology Co., Ltd. | Bao An District, Shenzhen | Guangdong | Contract manufacturer | 13 |
| Xiamen Newsound Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shenzhen Xiazhifeng Electronic Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 25 |
| Gerui Medical Products Co Ltd | Changzhou | Jiangsu | Manufacturer | 9 |
| Taizhou Honod Medical Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 7 |
Record
| Listed by | Bionix, LLC, United States |
|---|---|
| FDA product code | JYG |
| Device type | Curette, Ear |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-12-10 |
| Record revised | 2023-07-17 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2230 | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 108 |
| Sklar® | Sklar Corporation | 92 |
| Hayden Medical | Hayden Medical Inc | 73 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 68 |
| Boss Instruments | Boss Instruments, Ltd. | 60 |
| Buck EAR Curette | Sontec Instruments, Inc. | 59 |
| V. Mueller | Steris Corporation | 56 |
| Millennium | Avalign Technologies, Inc. | 56 |
| Novo Surgical | Novo Surgical, Inc. | 54 |
| BR Surgical, LLC | BR Surgical LLC | 52 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 47 |
| Pilling | Teleflex Medical LLC | 45 |
Showing 12 of 156. All products under Curette, Ear
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K852039 | 1985-06-11 |
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.