Atlas FDA

HAE

36 FDA 510(k) clearances · Product code

149 daysmedian time to decision
284 days90th percentile
36clearances measured

FDA profile

Official device name
Rongeur, Manual
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4840
Medical specialty
Neurology
Flags
Third-party review eligible
Adverse events (MAUDE)
2016: 34 · 2017: 25 · 2018: 29 · 2019: 24 · 2020: 25 · 2022: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Geister K-Rex rongeurs (K242759)Geister Medizin Technik GmbH2025-06-06
SQ.line KERRISON (K223596)Aesculap, Inc.2023-06-29
Rebellion, Phantom Multi-Bite Kerrison Rongeur (K230256)Morpheus AG2023-03-03
Rebellion; Phantom Multi-Bite Kerrison Rongeur (K221818)Morpheus AG2022-10-07
KLS Martin Neuro Rongeurs (K210741)KLS-Martin L.P.2022-06-03
Rebellion, Phantom Multi-Bite Kerrison Rongeur (K200768)Morpheus AG2021-05-04
Ace Medical Surgical Instruments (K200387)Ace Medical2020-07-21
Wiggins Medical Surgical Instruments (K200383)Wiggins Medical2020-07-21
Steribite (K180949)Rjr Surgical, Inc.2018-11-08
Symmetry Sharp Kerrison Rongeur (K161744)Symmetry Surgical, Inc.2016-09-07
Fehling-Punches (K153243)Fehling Instruments GmbH & Co. KG2016-08-04
Kerrison Rongeurs (K152734)Vitalitec Medizintechnik GmbH2016-06-18
Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs (K150468)K2 Medical GmbH & Co. KG2016-02-29
Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs (K150428)Integra Lifesciences Corp.2015-04-16
OSTEOMED NEURO RONGEUR (K131851)Osteomed2013-12-06
SYMMETRY KERRISON DISPOSABLE TIP RONGEURS (K130541)Symmetry Surgical2013-08-05
IO-TOME DEVICE (K113073)Baxano, Inc.2012-07-27
NEURO CHECK DEVICE WITH IO-FLEX WIRE (K113533)Baxano, Inc.2012-04-11
MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES (K100958)Baxano, Inc.2010-07-23
JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS (K092227)Integra Lifesciences Corp.2010-02-17
INSTRUMED RONGEUR (K081651)Instrumed International, Inc.2008-08-08
BAXANO ULTRA LOW PROFILE RONGEUR (K080494)Baxano, Inc.2008-03-04
MICROBLADE SHAVER AND ACCESSORIES (K063231)Baxano, Inc.2007-04-16
ULTRA LOW PROFILE RONGEUR (K062711)Baxano, Inc.2007-03-07
DAN KERRISON RONGEURS, MODELS K1 + BILLY 1 (K023868)Dannoritzer Medical Instruments2003-02-07
BRAY RONGEUR (K954699)Johnson & Johnson Professionals, Inc.1995-12-06
KERRISON RONGEURS (K943583)Enterprise Medical Corp.1995-02-21
ULTRA-LINE RONGEUR (K943635)V. Mueller Neuro/Spine1994-12-07
AUTO SUTURE KERRISON SPINAL RONGEUR (K943116)United States Surgical, A Division of Tyco Healthc1994-07-27
NEDBOND EJECTOR KERRISON RONGEUR (K933978)Redmond Neurotechnologies Corp.1994-01-12
INTERVERTEBRAL DISC RONGEUR (K903151)Von Zeppelin GmbH1990-12-11
SPECIAL RONGEUR (K903401)Sur-Med Instruments, Inc.1990-08-10
INSTRUMENTS FOR NEUROLOGICAL SURGERY (K901313)Von Zeppelin GmbH1990-07-23
LAMINECTOMY RONGEUR (K901372)Zeppelin GmbH1990-06-28
NEUROLOGICAL RONGEURS - VARIOUS TYPES (K892535)Zinnanti Surgical Instruments, Inc.1989-05-11
RONGEUR (NEUROSURGICAL INSTRUMENTS) (K875043)Solway, Inc.1988-01-22

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