Applier, Surgical, Clip

FDA product code GDO · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery

14510(k) clearances
0PMA approvals
5recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K926199Uniclip Surgical Clip ApplierGDO · Traditional Unisurge, Inc.04/20/1993SE
K890941Modified Suture Disp. Endoscopic Surgical Clip AppGDO · Traditional United States Surgical, A Division of Tyco Healthc04/07/1989SE
K890159Towel ClipsGDO · Traditional Dhason Brothers, Inc.02/03/1989SE
K890233Suture Clip Applier/RemoverGDO · Traditional Kinetic Medical Products01/27/1989SE
K820837Disposable Multiple Ligating ClipGDO · Traditional ETHICON, Inc.05/28/1982SE
K812291Ethicon Multiple Ligating Clip ApplierGDO · Traditional ETHICON, Inc.09/11/1981SE
K792378Hemospenser Cartridge Cat. No. 523500-GDO · Traditional Edward Weck, Inc.12/06/1979SE
K791845Bayonet Heifetz Clip AppliersGDO · Traditional Edward Weck, Inc.10/17/1979SE
K790855Surgical Drape Clip #201GDO · Traditional C. Intl.08/03/1979SE
K791157360 Hemoclip AppliersGDO · Traditional Edward Weck, Inc.06/27/1979SE
K790990Reynolds Double Hemoclip AppliersGDO · Traditional Edward Weck, Inc.06/05/1979SE
K772286Forceps, Suture, AutoGDO · Traditional Hartmann Group, Inc.12/20/1977SE
K771412Ligaclip Multiple Clip ApplierGDO · Traditional ETHICON, Inc.11/28/1977SE
K771640Suture Clip RemoverGDO · Traditional United States Surgical, A Division of Tyco Healthc09/30/1977SE

Recalls

RecallProductFirmInitiated
Z-2759-2016 Class IIWECK Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation…Misbranded: Incorrect etching on the device. Teleflex Medical08/24/2016Terminated
Z-1246-2016 Class IIIrrigation Clip 30; Intended to position and hold irrigation tubing during surgical…Assembled with the incorrect (smaller) front clips (component 44-0495 instead of 44.0498). The Anspach Effort, Inc.11/02/2015Terminated
Z-1777-2013 Class IILIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk non-sterile…Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple… Ethicon Endo-Surgery Inc04/12/2013Terminated
Z-1776-2013 Class IILIGACLIP Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Trays), 10mm…Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple… Ethicon Endo-Surgery Inc04/12/2013Terminated
Z-1775-2013 Class IILIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Product Usage: The…Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple… Ethicon Endo-Surgery Inc04/12/2013Terminated