PTE

Endoscopic Morcellator Gastroenterology

Product code

PTE

Device name

Endoscopic Morcellator Gastroenterology

Device class

Class 2

21 CFR

21 CFR 884.1690

Medical specialty

Obstetrics/Gynecology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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)

Definition text from the FDA device classification database (U.S. federal government work, public domain).