HAE — Rongeur, Manual Class II
FDA Device Classification
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 |