PTE · Class II · 21 CFR 884.1690

FDA Product Code PTE: Endoscopic Morcellator Gastroenterology

For Use In Endoscopic Procedures By A Trained Gastroenterologist To Resect And Remove Residual Tissue From The Peripheral Margins Following Emr (endoscopic Mucosal Resection)

Leading manufacturers include Interscope, Inc..

2
Total
2
Cleared
172d
Avg days
2017
Since

FDA 510(k) Cleared Endoscopic Morcellator Gastroenterology Devices (Product Code PTE)

2 devices
1–2 of 2
Cleared Jan 03, 2019
EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control
K181127
Interscope, Inc.
Gastroenterology & Urology · 248d

About Product Code PTE - Regulatory Context