Acu-Dispo-Curette
Acu-Dispo-Curette, Plus Assortment
4manufacturers in China registered for this device type
8catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Acuderm, Inc., United States |
|---|---|
| FDA product code | FZS |
| Device type | Curette, Surgical, General Use |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K891334 |
| Record published | 2020-09-22 |
| Record revised | 2024-11-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Packaging | Box of 25, box of 50, box of 100, pack of 100 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R02 | In distribution | |
| R01 | In distribution | |
| R04 | In distribution | |
| R05 | In distribution | |
| RCOMPL | In distribution | |
| RCOM | In distribution | |
| R07 | In distribution | |
| R03 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Life Instruments | Life Instrument Corp. | 1,651 |
| Sklar® | Sklar Corporation | 537 |
| gSource | Gsource, LLC. | 498 |
| Aesculap | Aesculap AG | 477 |
| Surtex | Surtex Instruments Ltd | 462 |
| HNM Medical | HNM Stainless, LLC. | 412 |
| Curette | Koros U.S.A., Inc. | 341 |
| Boss Instruments | Boss Instruments, Ltd. | 311 |
| Gen2 | Surgix Medical LLC | 301 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 295 |
| Symmetry Surgical | Aspen Surgical Products, Inc. | 248 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 192 |
Showing 12 of 245. All products under Curette, Surgical, General Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K891334 | 1989-04-11 |
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.