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U.S. Department of Health and Human Services

Product Classification

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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 CodeODE
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
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible