Device |
system, surgical, computer controlled instrument, remanufactured |
Regulation Description |
Endoscope and accessories. |
Definition |
As intended with the originally cleared instrument. |
Physical State |
A surgical instrument for a computer controlled system. The instrument has been remanufactured to extend its use life as compared to what was originally defined by the original equipment manufacturer. |
Technical Method |
Instrument is attached and manipulated from a primary computer controlled system. |
Target Area |
Where applicable in accordance to the indications for use. |
Regulation Medical Specialty |
Gastroenterology/Urology |
Review Panel |
General & Plastic Surgery |
Product Code | QSM |
Premarket Review |
General Surgery Devices
(DHT4A)
General Surgery Devices
(DHT4A)
|
Submission Type |
510(k)
|
Regulation Number |
876.1500
|
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
|
Third Party Review |
Not Third Party Eligible |