Device |
electrosurgical, cutting & coagulation accessories, laparoscopic & endoscopic, reprocessed |
Regulation Description |
Electrosurgical cutting and coagulation device and accessories. |
Definition |
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). |
Regulation Medical Specialty |
General & Plastic Surgery |
Review Panel |
General & Plastic Surgery |
Product Code | NUJ |
Premarket Review |
General Surgery Devices
(DHT4A)
General Surgery Devices
(DHT4A)
|
Submission Type |
510(k)
|
Regulation Number |
878.4400
|
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
|
Recognized Consensus Standard
|
Third Party Review |
Not Third Party Eligible |