US Endoscopy Group Inc

FDA Regulatory Profile

Summary

Total Recalls
10
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1011-2019Class IIUS Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for February 4, 2019
Z-1416-2017Class IIIRoth Net Polyp RetrievalDecember 13, 2016
Z-0289-2017Class IIVari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single usMay 18, 2016
Z-0001-2016Class IIHistolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endosJuly 14, 2015
Z-1453-2015Class IITalon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimensMarch 10, 2015
Z-1943-2015Class IIVelocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve iFebruary 17, 2015
Z-0861-2015Class IIUroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouOctober 31, 2014
Z-1099-2013Class IITorrent" irrigation tubing. Product Usage: The Torrent irrigation system (tubing and accessoMarch 7, 2013
Z-2396-2012Class IIInfinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, MDecember 22, 2011
Z-0006-2013Class IIEndoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreigNovember 14, 2011