HAE — Rongeur, Manual Class II
FDA product code HAE covers "Rongeur, Manual", a Class II medical device regulated under 21 CFR 882.4840. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HAE
- Device Class
- Class II
- Regulation Number
- 882.4840
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242759 | geister medizin technik | Geister K-Rex rongeurs | June 6, 2025 |
| K223596 | aesculap | SQ.line KERRISON | June 29, 2023 |
| K230256 | morpheus | Rebellion, Phantom Multi-Bite Kerrison Rongeur | March 3, 2023 |
| K221818 | morpheus | Rebellion; Phantom Multi-Bite Kerrison Rongeur | October 7, 2022 |
| K210741 | kls-martin l.p | KLS Martin Neuro Rongeurs | June 3, 2022 |
| K200768 | morpheus | Rebellion, Phantom Multi-Bite Kerrison Rongeur | May 4, 2021 |
| K200387 | ace medical | Ace Medical Surgical Instruments | July 21, 2020 |
| K200383 | wiggins medical | Wiggins Medical Surgical Instruments | July 21, 2020 |
| K180949 | rjr surgical | Steribite | November 8, 2018 |
| K161744 | symmetry surgical | Symmetry Sharp Kerrison Rongeur | September 7, 2016 |
| K153243 | fehling instruments gmbh and co. kg | Fehling-Punches | August 4, 2016 |
| K152734 | vitalitec medizintechnik | Kerrison Rongeurs | June 18, 2016 |
| K150468 | k2 medical gmbh and co. kg | Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs | February 29, 2016 |
| K150428 | integra lifesciences | Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) K | April 16, 2015 |
| K131851 | osteomed | OSTEOMED NEURO RONGEUR | December 6, 2013 |
| K130541 | symmetry surgical | SYMMETRY KERRISON DISPOSABLE TIP RONGEURS | August 5, 2013 |
| K113073 | baxano | IO-TOME DEVICE | July 27, 2012 |
| K113533 | baxano | NEURO CHECK DEVICE WITH IO-FLEX WIRE | April 11, 2012 |
| K100958 | baxano | MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES | July 23, 2010 |
| K092227 | integra lifesciences | JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS | February 17, 2010 |