HAE · Class II · 21 CFR 882.4840

FDA Product Code HAE: Rongeur, Manual

Leading manufacturers include Morpheus AG, Integra Lifesciences Corp. and Baxano, Inc..

36
Total
36
Cleared
156d
Avg days
1988
Since
Declining activity - 1 submissions in the last 2 years vs 3 in the prior period
Review times increasing: avg 267d recently vs 153d historically

FDA 510(k) Cleared Rongeur, Manual Devices (Product Code HAE)

36 devices
1–24 of 36
Cleared Jun 06, 2025
Geister K-Rex rongeurs
K242759
Geister Medizin Technik GmbH
Neurology · 267d
Cleared Jun 29, 2023
SQ.line KERRISON
K223596
Aesculap, Inc.
Neurology · 209d
Cleared Mar 03, 2023
Rebellion, Phantom Multi-Bite Kerrison Rongeur
K230256
Morpheus AG
Neurology · 31d
Cleared Oct 07, 2022
Rebellion
K221818
Morpheus AG
Neurology · 106d
Cleared Jun 03, 2022
KLS Martin Neuro Rongeurs
K210741
KLS-Martin L.P.
Neurology · 448d
Cleared May 04, 2021
Rebellion, Phantom Multi-Bite Kerrison Rongeur 
K200768
Morpheus AG
Neurology · 405d
Cleared Jul 21, 2020
Wiggins Medical Surgical Instruments
K200383
Wiggins Medical
Neurology · 154d
Cleared Jul 21, 2020
Ace Medical Surgical Instruments
K200387
Ace Medical
Neurology · 154d
Cleared Nov 08, 2018
Steribite
K180949
Rjr Surgical, Inc.
Neurology · 211d
Cleared Sep 07, 2016
Symmetry Sharp Kerrison Rongeur
K161744
Symmetry Surgical, Inc.
Neurology · 75d
Cleared Aug 04, 2016
Fehling-Punches
K153243
Fehling Instruments GmbH & Co. KG
Neurology · 269d
Cleared Jun 18, 2016
Kerrison Rongeurs
K152734
Vitalitec Medizintechnik GmbH
Neurology · 270d
Cleared Feb 29, 2016
Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs
K150468
K2 Medical GmbH & Co. KG
Neurology · 371d
Cleared Apr 16, 2015
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.
Neurology · 56d
Cleared Dec 06, 2013
OSTEOMED NEURO RONGEUR
K131851
Osteomed
Neurology · 168d
Cleared Aug 05, 2013
SYMMETRY KERRISON DISPOSABLE TIP RONGEURS
K130541
Symmetry Surgical
Neurology · 157d
Cleared Jul 27, 2012
IO-TOME DEVICE
K113073
Baxano, Inc.
Neurology · 284d
Cleared Apr 11, 2012
NEURO CHECK DEVICE WITH IO-FLEX WIRE
K113533
Baxano, Inc.
Neurology · 133d
Cleared Feb 17, 2010
JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS
K092227
Integra Lifesciences Corp.
Neurology · 209d
Cleared Dec 06, 1995
BRAY RONGEUR
K954699
Johnson & Johnson Professionals, Inc.
Neurology · 55d
Cleared Jul 27, 1994
AUTO SUTURE KERRISON SPINAL RONGEUR
K943116
United States Surgical, A Division of Tyco Healthc
Neurology · 30d
Cleared May 11, 1989
NEUROLOGICAL RONGEURS - VARIOUS TYPES
K892535
Zinnanti Surgical Instruments, Inc.
Neurology · 30d

About Product Code HAE - Regulatory Context

510(k) Submission Activity

36 total 510(k) submissions under product code HAE since 1988, with 36 receiving FDA clearance (average review time: 156 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.

FDA 510(k) Review Time - HAE Product Code

Recent submissions under HAE have taken an average of 267 days to reach a decision - up from 153 days historically. Manufacturers should account for longer review timelines in current project planning.

HAE devices are reviewed by the Neurology panel. Browse all Neurology devices →