Rongeur, Manual

FDA product code HAE · Class II (moderate risk) · 21 CFR 882.4840 · Neurology

36510(k) clearances
0PMA approvals
2recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K242759Geister K-Rex rongeursHAE · Traditional Geister Medizin Technik GmbH06/06/2025SE
K223596SQ.line KERRISONHAE · Traditional Aesculap, Inc.06/29/2023SE
K230256Rebellion, Phantom Multi-Bite Kerrison RongeurHAE · Special Morpheus AG03/03/2023SE
K221818Rebellion; Phantom Multi-Bite Kerrison RongeurHAE · Special Morpheus AG10/07/2022SE
K210741KLS Martin Neuro RongeursHAE · Traditional KLS-Martin L.P.06/03/2022SE
K200768Rebellion, Phantom Multi-Bite Kerrison RongeurHAE · Traditional Morpheus AG05/04/2021SE
K200387Ace Medical Surgical InstrumentsHAE · Traditional Ace Medical07/21/2020SE
K200383Wiggins Medical Surgical InstrumentsHAE · Traditional Wiggins Medical07/21/2020SE
K180949SteribiteHAE · Traditional Rjr Surgical, Inc.11/08/2018SE
K161744Symmetry Sharp Kerrison RongeurHAE · Special Symmetry Surgical, Inc.09/07/2016SE
K153243Fehling-PunchesHAE · Traditional Fehling Instruments GmbH & Co. KG08/04/2016SE
K152734Kerrison RongeursHAE · Traditional Vitalitec Medizintechnik GmbH06/18/2016SE
K150468Laminectomy Rongeurs, Kerrison Rongeurs, IVD RongeursHAE · Traditional K2 Medical GmbH & Co. KG02/29/2016SE
K150428Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison…HAE · Special Integra Lifesciences Corp.04/16/2015SE
K131851Osteomed Neuro RongeurHAE · Traditional Osteomed12/06/2013SE
K130541Symmetry Kerrison Disposable Tip RongeursHAE · Traditional Symmetry Surgical08/05/2013SE
K113073Io-Tome DeviceHAE · Traditional Baxano, Inc.07/27/2012SE
K113533Neuro Check Device with Io-Flex WireHAE · Special Baxano, Inc.04/11/2012SE
K100958Modification to: Microblade Shaver and AccessoriesHAE · Special Baxano, Inc.07/23/2010SE
K092227Jarit, Ruggles, R&B Redmond/ Redmond, Miltex, Meisterhand - Kerrison RongeursHAE · Traditional Integra Lifesciences Corp.02/17/2010SE
K081651Instrumed RongeurHAE · Traditional Instrumed International, Inc.08/08/2008SE
K080494Baxano Ultra Low Profile RongeurHAE · Special Baxano, Inc.03/04/2008SE
K063231Microblade Shaver and AccessoriesHAE · Traditional Baxano, Inc.04/16/2007SE
K062711Ultra Low Profile RongeurHAE · Traditional Baxano, Inc.03/07/2007SE
K023868Dan Kerrison Rongeurs, Models K1 + Billy 1HAE · Traditional Dannoritzer Medical Instruments02/07/2003SE
K954699Bray RongeurHAE · Traditional Johnson & Johnson Professionals, Inc.12/06/1995SE
K943583Kerrison RongeursHAE · Traditional Enterprise Medical Corp.02/21/1995SE
K943635Ultra-Line RongeurHAE · Traditional V. Mueller Neuro/Spine12/07/1994SE
K943116Auto Suture Kerrison Spinal RongeurHAE · Traditional United States Surgical, A Division of Tyco Healthc07/27/1994SE
K933978Nedbond Ejector Kerrison RongeurHAE · Traditional Redmond Neurotechnologies Corp.01/12/1994SE
K903151Intervertebral Disc RongeurHAE · Traditional Von Zeppelin GmbH12/11/1990SE
K903401Special RongeurHAE · Traditional Sur-Med Instruments, Inc.08/10/1990SE
K901313Instruments for Neurological SurgeryHAE · Traditional Von Zeppelin GmbH07/23/1990SE
K901372Laminectomy RongeurHAE · Traditional Zeppelin GmbH06/28/1990SE
K892535Neurological Rongeurs - Various TypesHAE · Traditional Zinnanti Surgical Instruments, Inc.05/11/1989SE
K875043Rongeur (Neurosurgical Instruments)HAE · Traditional Solway, Inc.01/22/1988SE

Recalls

RecallProductFirmInitiated
Z-0651-2025 Class IISmall DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that…Units were not intended for commercial distribution and inadvertently distributed. Folsom Metal Products, Inc.10/30/2023Open, Classified
Z-0650-2025 Class IIDKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in…Units were not intended for commercial distribution and inadvertently distributed. Folsom Metal Products, Inc.10/30/2023Open, Classified