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 On
| Device Type ID | 2151 |
| Device Name | Pediatric Esophageal Atresia Anastomosis Device |
| Physical State | Plastic Tubes, Neodymium Iron Boron Magnets |
| Technical Method | Uses Magnets Advanced Through Esophageal And Gastric Catheters To Bore Through Tissue And Create An Anastomosis. |
| Target Area | Atretic Esophageal Ends |
| Regulation Description | Gastrointestinal Tube And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Gastroenterology Devices Branch (GEDB) |
| Submission Type | HDE - Humanitarian Device Exem |
| CFR Regulation Number | 876.5980 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PTK |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2151 |
| Device | Pediatric Esophageal Atresia Anastomosis Device |
| Product Code | PTK |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Gastrointestinal Tube And Accessories. |
| CFR Regulation Number | 876.5980 [🔎] |
| Device Problems | |
|---|---|
Failure To Advance | 2 |
Patient-Device Incompatibility | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Off-Label Use | 1 |
| Total Device Problems | 5 |