Product code HAE
- Device name
- Rongeur, Manual
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.4840
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260446 | Tontarra Punches and Rongeurs | Tontarra Medizintechnik GmbH | 2026-09-15 |
| K242759 | Geister K-Rex rongeurs | Geister Medizin Technik GmbH | 2025-06-06 |
| K223596 | SQ.line KERRISON | Aesculap, Inc. | 2023-06-29 |
| K230256 | Rebellion, Phantom Multi-Bite Kerrison Rongeur | Morpheus AG | 2023-03-03 |
| K221818 | Rebellion; Phantom Multi-Bite Kerrison Rongeur | Morpheus AG | 2022-10-07 |
| K210741 | KLS Martin Neuro Rongeurs | KLS-Martin L.P. | 2022-06-03 |
| K200768 | Rebellion, Phantom Multi-Bite Kerrison Rongeur | Morpheus AG | 2021-05-04 |
| K200383 | Wiggins Medical Surgical Instruments | Wiggins Medical | 2020-07-21 |
| K200387 | Ace Medical Surgical Instruments | Ace Medical | 2020-07-21 |
| K180949 | Steribite | Rjr Surgical, Inc. | 2018-11-08 |
| K161744 | Symmetry Sharp Kerrison Rongeur | Symmetry Surgical, Inc. | 2016-09-07 |
| K153243 | Fehling-Punches | Fehling Instruments GmbH & Co. KG | 2016-08-04 |
| K152734 | Kerrison Rongeurs | Vitalitec Medizintechnik GmbH | 2016-06-18 |
| K150468 | Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs | K2 Medical GmbH & Co. KG | 2016-02-29 |
| 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. | 2015-04-16 |
| K131851 | OSTEOMED NEURO RONGEUR | Osteomed | 2013-12-06 |
| K130541 | SYMMETRY KERRISON DISPOSABLE TIP RONGEURS | Symmetry Surgical | 2013-08-05 |
| K113073 | IO-TOME DEVICE | Baxano, Inc. | 2012-07-27 |
| K113533 | NEURO CHECK DEVICE WITH IO-FLEX WIRE | Baxano, Inc. | 2012-04-11 |
| K100958 | MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES | Baxano, Inc. | 2010-07-23 |
| K092227 | JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS | Integra Lifesciences Corp. | 2010-02-17 |
| K081651 | INSTRUMED RONGEUR | Instrumed International, Inc. | 2008-08-08 |
| K080494 | BAXANO ULTRA LOW PROFILE RONGEUR | Baxano, Inc. | 2008-03-04 |
| K063231 | MICROBLADE SHAVER AND ACCESSORIES | Baxano, Inc. | 2007-04-16 |
| K062711 | ULTRA LOW PROFILE RONGEUR | Baxano, Inc. | 2007-03-07 |
| K023868 | DAN KERRISON RONGEURS, MODELS K1 + BILLY 1 | Dannoritzer Medical Instruments | 2003-02-07 |
| K954699 | BRAY RONGEUR | Johnson & Johnson Professionals, Inc. | 1995-12-06 |
| K943583 | KERRISON RONGEURS | Enterprise Medical Corp. | 1995-02-21 |
| K943635 | ULTRA-LINE RONGEUR | V. Mueller Neuro/Spine | 1994-12-07 |
| K943116 | AUTO SUTURE KERRISON SPINAL RONGEUR | United States Surgical, A Division of Tyco Healthc | 1994-07-27 |
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| 04255968301652 | Vitalitec | Vitalitec International Medizintechnik GmbH | 2026-09-18 |
| 04255968301607 | Vitalitec | Vitalitec International Medizintechnik GmbH | 2026-09-18 |
| 04255968301591 | Vitalitec | Vitalitec International Medizintechnik GmbH | 2026-09-18 |
| 04255968301546 | Vitalitec | Vitalitec International Medizintechnik GmbH | 2026-09-18 |
| 04255968301539 | Vitalitec | Vitalitec International Medizintechnik GmbH | 2026-09-18 |
| 04255968301485 | Vitalitec | Vitalitec International Medizintechnik GmbH | 2026-09-18 |
| 04255968301478 | Vitalitec | Vitalitec International Medizintechnik GmbH | 2026-09-18 |
| 04255968301430 | Vitalitec | Vitalitec International Medizintechnik GmbH | 2026-09-18 |
| 04255968301423 | Vitalitec | Vitalitec International Medizintechnik GmbH | 2026-09-18 |
| 04255968301416 | Vitalitec | Vitalitec International Medizintechnik GmbH | 2026-09-18 |
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| 04255968301362 | Vitalitec | Vitalitec International Medizintechnik GmbH | 2026-09-18 |
| 04255968301157 | Vitalitec | Vitalitec International Medizintechnik GmbH | 2026-09-18 |
| 04255968301171 | Vitalitec | Vitalitec International Medizintechnik GmbH | 2026-09-18 |
| 04255968301225 | Vitalitec | Vitalitec International Medizintechnik GmbH | 2026-09-18 |
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| 04255968301249 | Vitalitec | Vitalitec International Medizintechnik GmbH | 2026-09-18 |
| 04255968301287 | Vitalitec | Vitalitec International Medizintechnik GmbH | 2026-09-18 |
| 04255968301294 | Vitalitec | Vitalitec International Medizintechnik GmbH | 2026-09-18 |
| 04255968301300 | Vitalitec | Vitalitec International Medizintechnik GmbH | 2026-09-18 |
| 04255968301348 | Vitalitec | Vitalitec International Medizintechnik GmbH | 2026-09-18 |
| 04255968301355 | Vitalitec | Vitalitec International Medizintechnik GmbH | 2026-09-18 |
| 04255968301379 | Vitalitec | Vitalitec International Medizintechnik GmbH | 2026-09-18 |
| 00190776424008 | Millennium | Avalign Technologies, Inc. | 2026-08-27 |
| 00190776424084 | Millennium | Avalign Technologies, Inc. | 2026-08-27 |
| 00850003512006 | Steribite | Steribite, LLC | 2026-08-27 |
| 00850003512044 | Steribite | Steribite, LLC | 2026-08-27 |
| 00850003512082 | Steribite | Steribite, LLC | 2026-08-27 |