Device |
disposable joint aspiration/injection kit |
Regulation Description |
Manual surgical instrument for general use. |
Definition |
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.Fda.Gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080217.Pdf.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. |
Physical State |
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.Fda.Gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080217.Pdf.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. |
Technical Method |
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.Fda.Gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080217.Pdf.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. |
Target Area |
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.Fda.Gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080217.Pdf.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. |
Regulation Medical Specialty |
General & Plastic Surgery |
Review Panel |
Orthopedic |
Product Code | PPP |
Premarket Review |
Office of Orthopedic Devices
(OHT6)
Joint Arthroplasty Devices
(DHT6A)
|
Submission Type |
Enforcement Discretion
|
Regulation Number |
878.4800
|
Device Class |
1
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|