DeviceClearance

Product code QAG— Obstetrics/Gynecology

remOVE System

Classification name
Endoscopic Electrosurgical Clip Cutting System
Device class
Class 2
Regulation
21 CFR 876.4310
Advisory panel
Obstetrics/Gynecology
Total cleared
1
First cleared
Most recent

FDA classification definition

“To fragment metallic clips and remove them from the digestive tract.”

— U.S. Food and Drug Administration, device classification record for product code QAG under 21 CFR 876.4310, via openFDA

Market context for product code QAG

FDA has cleared 1 device under product code QAG, all in 2017, 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.

Top applicants under product code QAG

Recent clearances under product code QAG

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