# Pediatric Esophageal Atresia Anastomosis Device
> **Product code: PTK** · Class III — High Risk (PMA approval required, life-sustaining) · Gastroenterology, Urology · 21 CFR 876.5980
## Classification
- **FDA Product Code:** PTK
- **Device class:** Class III — High Risk (PMA approval required, life-sustaining)
- **Regulation:** 21 CFR 876.5980
- **Review panel:** GU
- **Medical specialty:** Gastroenterology, Urology
- **Submission type:** 6
- **GMP exempt:** N
- **Life sustaining:** Y
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PTK)
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