FDA product code PTK: Pediatric Esophageal Atresia Anastomosis Device
PTK is the FDA product code for pediatric esophageal atresia anastomosis device. It is a Class III device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel. Devices under PTK reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Pediatric Esophageal Atresia Anastomosis Device |
| Device class | Class III |
| Regulation | 21 CFR 876.5980 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | Unclassified |
| Life-sustaining or supporting | Yes |
Recalls for PTK devices
openFDA lists no recalls for product code PTK.
Frequently asked questions
What is FDA product code PTK?
PTK is the FDA product code for pediatric esophageal atresia anastomosis device. It is a Class III device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel.
What device class is PTK?
Class III, regulation 21 CFR 876.5980. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code PTK
- Run a recall and safety report across every PTK manufacturer
- Watch product code PTK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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