PTE — Endoscopic Morcellator Gastroenterology Class II
FDA product code PTE covers "Endoscopic Morcellator Gastroenterology", a Class II medical device regulated under 21 CFR 884.1690. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PTE
- Device Class
- Class II
- Regulation Number
- 884.1690
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Definition
For use in endoscopic procedures by a trained gastroenterologist to resect and remove residual tissue from the peripheral margins following EMR (Endoscopic Mucosal Resection)