Device |
arthroscope |
Regulation Description |
Arthroscope. |
Definition |
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). |
Regulation Medical Specialty |
Orthopedic |
Review Panel |
Orthopedic |
Product Code | HRX |
Premarket Review |
Office of Orthopedic Devices
(OHT6)
Restorative, Repair and Trauma Devices
(DHT6C)
|
Submission Type |
510(k)
|
Regulation Number |
888.1100
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Guidance Document
|
Third Party Review
|
Accredited Persons
|