Product code PTE

Device name

Endoscopic Morcellator Gastroenterology

Medical specialty

Obstetrics/Gynecology

Device class

2

Regulation number

884.1690

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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)

Source

FDA openFDA device classification dataset