HAE · Class II · 21 CFR 882.4840

FDA Product Code HAE: Rongeur, Manual

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

37
Total
37
Cleared
158d
Avg days
1988
Since
Stable submission activity - 2 submissions in the last 2 years
Review times increasing: avg 242d recently vs 153d historically

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

37 devices
1–24 of 37
Cleared Sep 15, 2026
Tontarra Punches and Rongeurs
K260446
Tontarra Medizintechnik GmbH
Neurology · 216d
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 Jul 23, 2010
MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES
K100958
Baxano, Inc.
Neurology · 107d
Cleared Feb 17, 2010
JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS
K092227
Integra Lifesciences Corp.
Neurology · 209d
Cleared Aug 08, 2008
INSTRUMED RONGEUR
K081651
Instrumed International, Inc.
Neurology · 57d
Cleared Mar 04, 2008
BAXANO ULTRA LOW PROFILE RONGEUR
K080494
Baxano, Inc.
Neurology · 11d
Cleared Apr 16, 2007
MICROBLADE SHAVER AND ACCESSORIES
K063231
Baxano, Inc.
Neurology · 173d

About Product Code HAE - Regulatory Context

510(k) Submission Activity

37 total 510(k) submissions under product code HAE since 1988, with 37 receiving FDA clearance (average review time: 158 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - HAE Product Code

Recent submissions under HAE have taken an average of 242 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 →