| Device |
endoscopic suture/plication system, gastroesophageal reflux disease (gerd) |
| Regulation Description |
Endoscope and accessories. |
| Definition |
To treat the symptoms of chronic gastroesophageal reflux disease (GERD), either by approximating tissue with sutures or plicating tissue with an implant. |
| Physical State |
may include: capsule assembly, needle assembly, guidewire, suture cutter, tubing, clip delivery device, clips or other implant, plication instrument, overtube, retractor |
| Technical Method |
Place sutures in soft tissue of stomach and esophagus, or deliver implant in stomach near gastroesophageal junction |
| Target Area |
gastroesophageal junction GEJ |
| Regulation Medical Specialty |
Gastroenterology/Urology |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | ODE |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
876.1500
|
|---|
| 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
|
|---|
| Recognized Consensus Standards
|
| Third Party Review |
Not Third Party Eligible |
|
|
