Device |
instrument, biopsy |
Regulation Description |
Gastroenterology-urology biopsy instrument. |
Regulation Medical Specialty |
Gastroenterology/Urology |
Review Panel |
General & Plastic Surgery |
Product Code | KNW |
Premarket Review |
General Surgery Devices
(DHT4A)
General Surgery Devices
(DHT4A)
|
Submission Type |
510(k)
|
Regulation Number |
876.1075
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Guidance Document
|
Third Party Review
|
Accredited Persons
|