Clip, Scalp

FDA product code HBO · Class II (moderate risk) · 21 CFR 882.4150 · Neurology

11510(k) clearances
0PMA approvals
3recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K253814Raney Clips KitHBO · Traditional Beijing Honghugaoxiang Science and Technology…07/21/2026SE
K050044Medtronic Clip Gun KitHBO · Special Medtronic Neurosurgery02/07/2005SE
K033660Storz Raney Scalp Clip, Model 1-20-004-05HBO · Traditional Rudolf Storz GmbH01/07/2004SE
K012219Scalpfix Clip SystemHBO · Special Aesculap, Inc.07/31/2001SE
K944311Acra-CutHBO · Traditional Acra Cut, Inc.11/18/1994SE
K905433Codman Disposable Scalp Clip ApplierHBO · Traditional Codman & Shurtleff, Inc.02/21/1991SE
K896723Clip Gun with Raney Type Scalp ClipsHBO · Traditional Omni Medical Designs03/23/1990SE
K894778Codman RF-12 Disposable Scalp Clip ApplierHBO · Traditional Codman & Shurtleff, Inc.12/06/1989SE
K890443Caspar Scalp Clip, ApplierHBO · Traditional Aesculap Instruments Corp.06/15/1989SE
K883963Raney and Leroy-Raney Scalp ClipHBO · Traditional New England Surgical Instrument Corp.10/07/1988SE
K881265Raney ClipsHBO · Traditional Zimmer, Inc.05/31/1988SE

Recalls

RecallProductFirmInitiated
Z-2224-2021 Class IICODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to…Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile… Integra LifeSciences Corp.06/01/2021Terminated
Z-3212-2018 Class IIMedtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed…The packaging sterile barrier does not comply with the applicable packaging standard for terminally… Medtronic Neurosurgery05/03/2018Terminated
Z-0622-2018 Class IIModel #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, Medtronic…Medtronic is initiating a voluntary recall because the products identified above did not adequately… Medtronic Neurosurgery12/20/2017Terminated