Device |
endoscopic tissue approximation device |
Regulation Description |
Endoscope and accessories. |
Definition |
To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue. |
Physical State |
may include: delivery instrument, applier, holder, connector, threading tool, needle-loading tool, ring implant, pin implant, knot pusher, sutures, staples, clips, tackers, fasteners |
Technical Method |
Many methods to perform intended use. Insert instrument through endoscope at desired area of delivery. |
Target Area |
Various tissues located within body cavities, hollow organs, and canals in GI and GU tract. |
Regulation Medical Specialty |
Gastroenterology/Urology |
Review Panel |
Gastroenterology/Urology |
Product Code | OCW |
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? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|