Product Code: HAE
FDA class 2
21 CFR 882.4840
Rongeur, Manual
Neurology
The Manual Rongeur is a hand-held neurosurgical instrument with a strong, hinged jaw used to bite away and remove small pieces of bone or other hard tissue during cranial and spinal surgical procedures. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is HAE under regulation 21 CFR 882.4840 in the Neurology specialty. It is eligible for third-party 510(k) review.
510(k)s
36
FEI Numbers
58
Registration Numbers
58
Unique Applicants
27
Years Active
37
Basic Information
- Product Code
- HAE
- Device Class
- FDA class 2
- Regulation Number
- 882.4840
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 36 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K242759 | Geister K-Rex rongeurs | Jun 06, 2025 | Substantially Equivalent | Geister Medizin Technik GmbH |
| K223596 | SQ.line KERRISON | Jun 29, 2023 | Substantially Equivalent | Aesculap Inc. |
| K230256 | Rebellion, Phantom Multi-Bite Kerrison Rongeur | Mar 03, 2023 | Substantially Equivalent | Morpheus AG |
| K221818 | Rebellion; Phantom Multi-Bite Kerrison Rongeur | Oct 07, 2022 | Substantially Equivalent | Morpheus AG |
| K210741 | KLS Martin Neuro Rongeurs | Jun 03, 2022 | Substantially Equivalent | KLS-MARTIN L.P. |
| K200768 | Rebellion, Phantom Multi-Bite Kerrison Rongeur | May 04, 2021 | Substantially Equivalent | Morpheus AG |
| K200387 | Ace Medical Surgical Instruments | Jul 21, 2020 | Substantially Equivalent | Ace Medical |
| K200383 | Wiggins Medical Surgical Instruments | Jul 21, 2020 | Substantially Equivalent | Wiggins Medical |
| K180949 | Steribite | Nov 08, 2018 | Substantially Equivalent | RJR Surgical, Inc. |
| K161744 | Symmetry Sharp Kerrison Rongeur | Sep 07, 2016 | Substantially Equivalent | Symmetry Surgical Inc. |
| K153243 | Fehling-Punches | Aug 04, 2016 | Substantially Equivalent | Fehling Instruments GmbH & Co. KG |
| K152734 | Kerrison Rongeurs | Jun 18, 2016 | Substantially Equivalent | VITALITEC MEDIZINTECHNIK GMBH |
| K150468 | Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs | Feb 29, 2016 | Substantially Equivalent | K2 Medical GmbH & Co. KG |
| K150428 | 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 | Apr 16, 2015 | Substantially Equivalent | INTEGRA LIFESCIENCES CORP. |
| K131851 | OSTEOMED NEURO RONGEUR | Dec 06, 2013 | Substantially Equivalent | OSTEOMED |
| K130541 | SYMMETRY KERRISON DISPOSABLE TIP RONGEURS | Aug 05, 2013 | Substantially Equivalent | SYMMETRY SURGICAL |
| K113073 | IO-TOME DEVICE | Jul 27, 2012 | Substantially Equivalent | BAXANO, INC. |
| K113533 | NEURO CHECK DEVICE WITH IO-FLEX WIRE | Apr 11, 2012 | Substantially Equivalent | BAXANO, INC. |
| K100958 | MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES | Jul 23, 2010 | Substantially Equivalent | BAXANO, INC. |
| K092227 | JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS | Feb 17, 2010 | Substantially Equivalent | INTEGRA LIFESCIENCES CORP. |
| K081651 | INSTRUMED RONGEUR | Aug 08, 2008 | Substantially Equivalent | INSTRUMED INTERNATIONAL, INC. |
| K080494 | BAXANO ULTRA LOW PROFILE RONGEUR | Mar 04, 2008 | Substantially Equivalent | BAXANO, INC. |
| K063231 | MICROBLADE SHAVER AND ACCESSORIES | Apr 16, 2007 | Substantially Equivalent | BAXANO, INC. |
| K062711 | ULTRA LOW PROFILE RONGEUR | Mar 07, 2007 | Substantially Equivalent | BAXANO, INC. |
| K023868 | DAN KERRISON RONGEURS, MODELS K1 + BILLY 1 | Feb 07, 2003 | Substantially Equivalent | DANNORITZER MEDICAL INSTRUMENTS |
| K954699 | BRAY RONGEUR | Dec 06, 1995 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K943583 | KERRISON RONGEURS | Feb 21, 1995 | Substantially Equivalent | ENTERPRISE MEDICAL CORP. |
| K943635 | ULTRA-LINE RONGEUR | Dec 07, 1994 | Substantially Equivalent | V. MUELLER NEURO/SPINE |
| K943116 | AUTO SUTURE KERRISON SPINAL RONGEUR | Jul 27, 1994 | Substantially Equivalent | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K933978 | NEDBOND EJECTOR KERRISON RONGEUR | Jan 12, 1994 | Substantially Equivalent | REDMOND NEUROTECHNOLOGIES CORP. |
| K903151 | INTERVERTEBRAL DISC RONGEUR | Dec 11, 1990 | Substantially Equivalent | VON ZEPPELIN GMBH |
| K903401 | SPECIAL RONGEUR | Aug 10, 1990 | Substantially Equivalent | SUR-MED INSTRUMENTS, INC. |
| K901313 | INSTRUMENTS FOR NEUROLOGICAL SURGERY | Jul 23, 1990 | Substantially Equivalent | VON ZEPPELIN GMBH |
| K901372 | LAMINECTOMY RONGEUR | Jun 28, 1990 | Substantially Equivalent | ZEPPELIN GMBH |
| K892535 | NEUROLOGICAL RONGEURS - VARIOUS TYPES | May 11, 1989 | Substantially Equivalent | ZINNANTI SURGICAL INSTRUMENTS, INC. |
| K875043 | RONGEUR (NEUROSURGICAL INSTRUMENTS) | Jan 22, 1988 | Substantially Equivalent | SOLWAY, INC. |
FEI Numbers
This FDA classification entry is associated with 58 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 58 registration numbers. Click on an entry to view related FDA registrations.