Device |
pancreatic stent, covered, metallic, removable |
Definition |
To facilitate transmural endoscopic drainage of pancreatic pseudocysts |
Physical State |
stent and delivery system, endoscope |
Technical Method |
Facilitates and secures the apposition of tissue for transmural placement of stent |
Target Area |
pancreatic pseudocysts adherent to bowel wall |
Regulation Medical Specialty |
Gastroenterology/Urology |
Review Panel |
Gastroenterology/Urology |
Product Code | PCU |
Premarket Review |
GastroRenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
|
Submission Type |
510(k)
|
Regulation Number |
876.5015
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|