| Device |
deflation needle for removal of intragastric balloon |
| Definition |
Deflation needle is a prescription use device intended to puncture and drain fluid from an intragastric balloon so that the empty balloon may be removed endoscopically. |
| Physical State |
Deflation needle comprises a polyethylene tubing with a conical stainless steel fitting on the distal end, a removable wire with a needle on the distal end and a handle with Luer fitting. |
| Technical Method |
Needle/Catheter is advanced down the working channel of an endoscope. The distal end is placed adjacent to the balloon. The needle is unlocked at the handle and advanced from inside the tubing to puncture the balloon. The conical fitting is advanced into the balloon, the needle is removed, and suction is applied to the tubing. Fluid is drained from the balloon until the balloon is fully collapsed. The collapsed balloon may then be removed from the stomach with wire graspers. |
| Target Area |
Intragastric |
| Regulation Medical Specialty |
Gastroenterology/Urology |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | SCB |
|---|
| Premarket Review |
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
876.1550
|
|---|
| 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 |
