510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DEN160014Unknown

remOVE System

Ovesco Endoscopy AG, Tuebingen, DE / Direct, Unknown
FDA source (opens on fda.gov)

DEN160014 is the FDA 510(k) clearance record for remOVE System, a class II device, cleared for Ovesco Endoscopy AG on under FDA product code QAG (Endoscopic Electrosurgical Clip Cutting System). FDA's definition for product code QAG reads: "To fragment metallic clips and remove them from the digestive tract". FDA records list 14 510(k) clearances for Ovesco Endoscopy AG, from to . As of , FDA records show no recalls naming DEN160014.

Clearance record

Decision date
Received
(620 days to decision)
Product code
QAG Endoscopic Electrosurgical Clip Cutting System
Regulation
21 CFR 876.4310
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Ovesco Endoscopy AG Dorfackerstrasse 26, Tuebingen, DE
Third party review
No

Clearances, product code QAG

Trailing 12 months

FDA records hold no clearances under product code QAG in the trailing twelve months.

FDA records show no clearances under product code QAG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QAG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260