Device |
piston syringe lever |
Regulation Description |
Piston syringe. |
Definition |
Controlled compression of a piston syringe |
Physical State |
Syringe holder with proximal advancement mechanism which places pressure through means of a screw lever and manual proximal screw-down control wheel |
Technical Method |
Precision compression to proximal end of a syringe through means of a lever. |
Target Area |
Urology |
Regulation Medical Specialty |
General Hospital |
Review Panel |
General Hospital |
Product Code | QBL |
Premarket Review |
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
|
Submission Type |
510(k)
|
Regulation Number |
880.5860
|
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
|
Accredited Persons
|