Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4840](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4840) → HAE — Rongeur, Manual # HAE · Rongeur, Manual _Neurology · 21 CFR 882.4840 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE ## Overview - **Product Code:** HAE - **Device Name:** Rongeur, Manual - **Regulation:** [21 CFR 882.4840](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4840) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **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](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE/K242759.md) | Geister K-Rex rongeurs | Geister Medizin Technik GmbH | Jun 6, 2025 | SESE | | [K223596](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE/K223596.md) | SQ.line KERRISON | Aesculap, Inc. | Jun 29, 2023 | SESE | | [K230256](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE/K230256.md) | Rebellion, Phantom Multi-Bite Kerrison Rongeur | Morpheus AG | Mar 3, 2023 | SESE | | [K221818](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE/K221818.md) | Rebellion; Phantom Multi-Bite Kerrison Rongeur | Morpheus AG | Oct 7, 2022 | SESE | | [K210741](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE/K210741.md) | KLS Martin Neuro Rongeurs | KLS-Martin L.P. | Jun 3, 2022 | SESE | | [K200768](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE/K200768.md) | Rebellion, Phantom Multi-Bite Kerrison Rongeur | Morpheus AG | May 4, 2021 | SESE | | [K200387](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE/K200387.md) | Ace Medical Surgical Instruments | Ace Medical | Jul 21, 2020 | SESE | | [K200383](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE/K200383.md) | Wiggins Medical Surgical Instruments | Wiggins Medical | Jul 21, 2020 | SESE | | [K180949](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE/K180949.md) | Steribite | Rjr Surgical, Inc. | Nov 8, 2018 | SESE | | [K161744](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE/K161744.md) | Symmetry Sharp Kerrison Rongeur | Symmetry Surgical, Inc. | Sep 7, 2016 | SESE | | [K153243](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE/K153243.md) | Fehling-Punches | Fehling Instruments GmbH & Co. KG | Aug 4, 2016 | SESE | | [K152734](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE/K152734.md) | Kerrison Rongeurs | Vitalitec Medizintechnik GmbH | Jun 18, 2016 | SESE | | [K150468](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE/K150468.md) | Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs | K2 Medical GmbH & Co. KG | Feb 29, 2016 | SESE | | [K150428](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE/K150428.md) | 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](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE/K131851.md) | OSTEOMED NEURO RONGEUR | Osteomed | Dec 6, 2013 | SESE | | [K130541](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE/K130541.md) | SYMMETRY KERRISON DISPOSABLE TIP RONGEURS | Symmetry Surgical | Aug 5, 2013 | SESE | | [K113073](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE/K113073.md) | IO-TOME DEVICE | Baxano, Inc. | Jul 27, 2012 | SESE | | [K113533](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE/K113533.md) | NEURO CHECK DEVICE WITH IO-FLEX WIRE | Baxano, Inc. | Apr 11, 2012 | SESE | | [K100958](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE/K100958.md) | MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES | Baxano, Inc. | Jul 23, 2010 | SESE | | [K092227](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE/K092227.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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