PTK — Pediatric Esophageal Atresia Anastomosis Device Class III
FDA product code PTK covers "Pediatric Esophageal Atresia Anastomosis Device", a Class III medical device regulated under 21 CFR 876.5980. Submissions are reviewed by the Gastroenterology, Urology panel.
Classification Details
- Product Code
- PTK
- Device Class
- Class III
- Regulation Number
- 876.5980
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
Lengthening atretic esophageal ends < 4cm apart and creating an anastomosis with a non-surgical procedure in pediatric patients, up to one year of age with esophageal atresia without a tracheoesophageal fistula (TEF) or in pediatric patients up to one year of age for whom a concurrent TEF has been closed as a result of a prior procedure. The procedure is performed with magnets inserted through an esophageal and gastric catheter.