Arthroscope
RFB, 4MM, 30 Degree HD Quicklatch Autoclavable Cartridge Scope
21manufacturers in China registered for this device type
20catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (7), Jiangsu (6), Guangdong (5). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Peter’s Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Jiangsu Shenli Medical Production Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
| PAN-International Precision Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
Showing 12 of 21. All 21 manufacturers in China registered for Arthroscope
Record
| Listed by | ConMed Corporation, United States |
|---|---|
| FDA product code | HRX |
| Device type | Arthroscope |
| Device class | Class 2 |
| Regulation | 21 CFR 888.1100 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K962075 |
| Record published | 2016-09-24 |
| Record revised | 2023-11-17 (version 5) |
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, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: KEEP DRY |
| Sizes | Angle 30 to 70 °; outer diameter 4 mm; length 3.5 in |
| Distribution end date | 2024-07-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E9010RFB | In distribution | |
| TRL4300 | In distribution | |
| E9005RFB | Withdrawn | |
| HD4301RFB | Outer Diameter 4 mm | Withdrawn |
| HD4001 | Outer Diameter 4 mm | Withdrawn |
| T2530RFB | Angle 30 ° | Withdrawn |
| HD4300RFB | Angle 30 ° | Withdrawn |
| T4300 | Autoclavable Eyecup Scope | Withdrawn |
| 83210 | Length 3.5 in | Withdrawn |
| T4700 | Autoclavable Eyecup Scope | Withdrawn |
| T1901 | Withdrawn | |
| E9000G | Withdrawn | |
| HD4302 | Outer Diameter 4 mm | Withdrawn |
| E9000J | Withdrawn | |
| E9000 | Withdrawn | |
| HD4700RFB | Outer Diameter 4 mm | Withdrawn |
| 60-3950-038 | Removable Lock | Withdrawn |
| T2501 | Withdrawn | |
| 60-3950-039 | Removable Lock | Withdrawn |
| 8720 | Rectangular Patellar Tendon Graft Template | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 299 |
| Arthroscope | Karl Storz GmbH & Co. KG | 278 |
| Conmed/Linvatec | Provision | 265 |
| Arthroscope | Smith & Nephew, Inc. | 255 |
| Medline | Medline Industries, Inc. | 205 |
| Arthroscope | Sterilmed, Inc. | 184 |
| Sustainable Technologies | Provision | 150 |
| Medline Renewal | Medline Industries, Inc. | 123 |
| Stryker | Provision | 113 |
| Arthrex® | Arthrex, Inc. | 109 |
| Arthrex | Provision | 109 |
| Eberle | Eberle GmbH & Co. KG | 92 |
Showing 12 of 567. All products under Arthroscope
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182882 | 2018-11-14 |
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.