Arthroscope
Stubby Endoscope, Autoclavable, C-Mount, Reverse Cant, 30 Degree View Direction
21manufacturers in China registered for this device type
39catalogue numbers in this listing
12510(k) clearances naming this product code
19recalls on this code
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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | HRX |
| Device type | Arthroscope |
| Device class | Class 2 |
| Regulation | 21 CFR 888.1100 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K935237 |
| Record published | 2016-09-23 |
| Record revised | 2022-09-16 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Hydrogen Peroxide, Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 40 °C; Storage environment humidity 10 to 75 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal |
| Packaging | Pack of 5 |
| Sizes | Outer diameter 1.9 to 4 mm; needle gauge 13 to 19 G; length 15.24 cm; length 3 to 9 in; angle 30 ° |
| Distribution end date | 2022-04-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0295800300 | In distribution | |
| 0407254000 | Length 15.24 cm | In distribution |
| 0407250000 | Needle Gauge 17.0 G | In distribution |
| 0407276000 | Needle Gauge 15.0 G | In distribution |
| 0407255000 | Length 15.24 cm | In distribution |
| 0407251000 | Needle Gauge 17.0 G | In distribution |
| 0407281000 | Length 3.0 in | In distribution |
| 0407253000 | Length 15.24 cm | In distribution |
| 0407260000 | Needle Gauge 17.0 G | In distribution |
| 0233032107 | In distribution | |
| 0407275000 | Needle Gauge 13.0 G | In distribution |
| 0502527130 | Outer Diameter 4.0 mm | In distribution |
| 0502144030 | Outer Diameter 1.9 mm | In distribution |
| 0502677070 | Outer Diameter 4.0 mm | In distribution |
| 0295800000 | In distribution | |
| 4100134000 | Diameter: 3.17 Millimeter | In distribution |
| 0407280000 | Needle Gauge 19.0 G | In distribution |
| 4100133000 | Diameter: 6.35 Millimeter | In distribution |
| 0502677030 | Outer Diameter 4.0 mm | In distribution |
| 0272700000 | In distribution | |
| 0502527030 | Outer Diameter 4.0 mm | In distribution |
| 0502477031 | Outer Diameter 4.0 mm | Withdrawn |
| 0502144010 | Outer Diameter 1.9 mm | Withdrawn |
| 0502427030 | Outer Diameter 4.0 mm | Withdrawn |
| 0502477131 | Angle 30.0 ° | Withdrawn |
| 4226120000 | Withdrawn | |
| 0502477011 | Outer Diameter 4.0 mm | Withdrawn |
| 0502427010 | Outer Diameter 4.0 mm | Withdrawn |
| 4212000000 | Withdrawn | |
| 0502427130 | Outer Diameter 4.0 mm | Withdrawn |
| 4222120000 | Withdrawn | |
| 4112000000 | Withdrawn | |
| 4215000000 | Withdrawn | |
| 0502142010 | Withdrawn | |
| 4110112000 | Withdrawn | |
| 0242720025 | Withdrawn | |
| 4300000000 | Withdrawn | |
| 0502526130 | Outer Diameter 2.7 mm | Withdrawn |
| 0502527070 | Outer Diameter 4.0 mm | 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 |
|---|---|
| K202659 | 2020-12-01 |
| K191259 | 2019-07-12 |
| K183470 | 2019-01-07 |
| K181752 | 2018-12-21 |
| K172116 | 2018-01-25 |
| K162062 | 2016-11-01 |
| K151932 | 2016-03-31 |
| K130430 | 2013-05-23 |
| K943323 | 1994-11-28 |
| K910858 | 1991-05-23 |
| K811861 | 1981-07-16 |
| K771200 | 1977-07-21 |
Recalls
17 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 |
|---|---|---|---|---|---|
| 2019-07-25 | Class II | Packaging | The seal integrity of the sterile bag containing the kits may be compromised. | 53 | 2020-09-24 |
| 2019-07-25 | Class II | Packaging | The seal integrity of the sterile bag containing the kits may be compromised. | 94 | 2020-09-24 |
| 2019-07-25 | Class II | Packaging | The seal integrity of the sterile bag containing the kits may be compromised. | 21 | 2020-09-24 |
| 2019-07-25 | Class II | Packaging | The seal integrity of the sterile bag containing the kits may be compromised. | 2248 | 2020-09-24 |
| 2019-07-25 | Class II | Packaging | The seal integrity of the sterile bag containing the kits may be compromised. | 259 | 2020-09-24 |
| 2019-07-25 | Class II | Packaging | The seal integrity of the sterile bag containing the kits may be compromised. | 110 | 2020-09-24 |
| 2019-07-25 | Class II | Packaging | The seal integrity of the sterile bag containing the kits may be compromised. | 1959 | 2020-09-24 |
| 2019-07-25 | Class II | Packaging | The seal integrity of the sterile bag containing the kits may be compromised. | 251 | 2020-09-24 |
| 2019-07-25 | Class II | Packaging | The seal integrity of the sterile bag containing the kits may be compromised. | 35 | 2020-09-24 |
| 2019-07-25 | Class II | Packaging | The seal integrity of the sterile bag containing the kits may be compromised. | 76 | 2020-09-24 |
| 2019-07-25 | Class II | Packaging | The seal integrity of the sterile bag containing the kits may be compromised. | 476 | 2020-09-24 |
| 2019-07-25 | Class II | Packaging | The seal integrity of the sterile bag containing the kits may be compromised. | 1533 | 2020-09-24 |
| 2019-07-25 | Class II | Packaging | The seal integrity of the sterile bag containing the kits may be compromised. | 28 | 2020-09-24 |
| 2019-04-30 | Class II | Under Investigation by firm | The seal integrity of the sterile bag containing the kits may be compromised. | 1600 | 2020-09-18 |
| 2019-04-30 | Class II | Under Investigation by firm | The seal integrity of the sterile bag containing the kits may be compromised. | 447 | 2020-09-18 |
| 2017-11-09 | Class II | Environmental control | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | 504 | 2019-04-16 |
| 2013-11-04 | Class II | Device Design | Stryker has identified a potential for the auger and/or cannula to fracture when the Dekompressor is used contrary to the warnings in the Instructions For Use (IFU). Specifically, manually bending the cannula can weaken the device and may r | 20,385 total distributed since 2004 | 2014-04-29 |
| 2011-02-03 | Not classified | Other | The firm received five complaints that the stylet did not fit down the cannula. The investigation revealed that the incorrect probe assembly was packaged for two DeKompressor part numbers with the lot number of 10214012. | 44 units both products | 2011-06-01 |
| 2011-02-03 | Not classified | Other | The firm received five complaints that the stylet did not fit down the cannula. The investigation revealed that the incorrect probe assembly was packaged for two DeKompressor part numbers with the lot number of 10214012. | 44 units both products | 2011-06-01 |
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.