DeviceClearance

Product code PTE— Obstetrics/Gynecology

EndoRotor

Classification name
Endoscopic Morcellator Gastroenterology
Device class
Class 2
Regulation
21 CFR 884.1690
Advisory panel
Obstetrics/Gynecology
Total cleared
2
First cleared
Most recent

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)”

— U.S. Food and Drug Administration, device classification record for product code PTE under 21 CFR 884.1690, via openFDA

Market context for product code PTE

FDA has cleared 2 devices under product code PTE between 2017 and 2019, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PTE

Recent clearances under product code PTE

Data sourced from openFDA. This site is unofficial and independent of the FDA.