Device |
ophthalmic needle |
Regulation Description |
Hypodermic single lumen needle. |
Definition |
An Ophthalmic Needle is a needle intended for intraocular injections. The device should be used by health care professionals to perform injections into the eye. |
Physical State |
sterile hypodermic needles |
Technical Method |
An Ophthalmic Needle is to be used to inject fluids into or withdraw fluids from the eye. |
Target Area |
The device is intended for injections into the eye. |
Regulation Medical Specialty |
General Hospital |
Review Panel |
General Hospital |
Product Code | QYM |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
|
Submission Type |
510(k)
|
Regulation Number |
880.5570
|
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 |