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Wilson-Cook Medical Inc./Cook Endoscopy

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories3
Latest FDA decision2019-12-19
TypeNumberDevice NameCodeDateActions
510(k) K190829 Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)FBK2019-12-19 View
510(k) K172665 Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cordsKNS2018-05-24 View
510(k) K172288 Fusion OMNI SphincterotomeKNS2018-04-17 View
510(k) K171993 Zimmon Needle Knife PapillotomeKNS2017-08-17 View
510(k) K171607 Bronchi and Gastrointestinal Cytology BrushFDX2017-07-31 View