HAE · Rongeur, Manual
Neurology · 21 CFR 882.4840 · Class 2
Overview
| Product Code | HAE |
|---|---|
| Device Name | Rongeur, Manual |
| Regulation | 21 CFR 882.4840 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 36)
Showing 20 most recent of 36 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242759 | Geister K-Rex rongeurs | Geister Medizin Technik GmbH | Jun 6, 2025 | SESE |
| K223596 | SQ.line KERRISON | Aesculap, Inc. | Jun 29, 2023 | SESE |
| K230256 | Rebellion, Phantom Multi-Bite Kerrison Rongeur | Morpheus AG | Mar 3, 2023 | SESE |
| K221818 | Rebellion; Phantom Multi-Bite Kerrison Rongeur | Morpheus AG | Oct 7, 2022 | SESE |
| K210741 | KLS Martin Neuro Rongeurs | KLS-Martin L.P. | Jun 3, 2022 | SESE |
| K200768 | Rebellion, Phantom Multi-Bite Kerrison Rongeur | Morpheus AG | May 4, 2021 | SESE |
| K200387 | Ace Medical Surgical Instruments | Ace Medical | Jul 21, 2020 | SESE |
| K200383 | Wiggins Medical Surgical Instruments | Wiggins Medical | Jul 21, 2020 | SESE |
| K180949 | Steribite | Rjr Surgical, Inc. | Nov 8, 2018 | SESE |
| K161744 | Symmetry Sharp Kerrison Rongeur | Symmetry Surgical, Inc. | Sep 7, 2016 | SESE |
| K153243 | Fehling-Punches | Fehling Instruments GmbH & Co. KG | Aug 4, 2016 | SESE |
| K152734 | Kerrison Rongeurs | Vitalitec Medizintechnik GmbH | Jun 18, 2016 | SESE |
| K150468 | Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs | K2 Medical GmbH & Co. KG | Feb 29, 2016 | SESE |
| 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 | Integra Lifesciences Corp. | Apr 16, 2015 | SESE |
| K131851 | OSTEOMED NEURO RONGEUR | Osteomed | Dec 6, 2013 | SESE |
| K130541 | SYMMETRY KERRISON DISPOSABLE TIP RONGEURS | Symmetry Surgical | Aug 5, 2013 | SESE |
| K113073 | IO-TOME DEVICE | Baxano, Inc. | Jul 27, 2012 | SESE |
| K113533 | NEURO CHECK DEVICE WITH IO-FLEX WIRE | Baxano, Inc. | Apr 11, 2012 | SESE |
| K100958 | MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES | Baxano, Inc. | Jul 23, 2010 | SESE |
| K092227 | JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS | Integra Lifesciences Corp. | Feb 17, 2010 | SESE |
Top Applicants
- Baxano, Inc. — 6 clearances
- Morpheus AG — 3 clearances
- Integra Lifesciences Corp. — 2 clearances
- Von Zeppelin GmbH — 2 clearances
- Ace Medical — 1 clearance
