KLS Martin Neuro Rongeurs
FDA 510(k) clearance K210741 · decided 2022-06-03
Clearance details
- K-number
- K210741
- Device name
- KLS Martin Neuro Rongeurs
- Applicant
- KLS-Martin L.P.
- Decision
- Substantially Equivalent
- Date received
- 2021-03-12
- Decision date
- 2022-06-03
- Days to decision
- 448 days
- Clearance type
- Traditional
- Product code
- HAE
- Device class
- 2
- Regulation number
- 882.4840
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Jacksonville, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Geister K-Rex rongeurs (K242759) | Geister Medizin Technik GmbH | 2025-06-06 |
| SQ.line KERRISON (K223596) | Aesculap, Inc. | 2023-06-29 |
| Rebellion, Phantom Multi-Bite Kerrison Rongeur (K230256) | Morpheus AG | 2023-03-03 |
| Rebellion; Phantom Multi-Bite Kerrison Rongeur (K221818) | Morpheus AG | 2022-10-07 |
| Rebellion, Phantom Multi-Bite Kerrison Rongeur (K200768) | Morpheus AG | 2021-05-04 |
| Ace Medical Surgical Instruments (K200387) | Ace Medical | 2020-07-21 |
| Wiggins Medical Surgical Instruments (K200383) | Wiggins Medical | 2020-07-21 |
| Steribite (K180949) | Rjr Surgical, Inc. | 2018-11-08 |
| Symmetry Sharp Kerrison Rongeur (K161744) | Symmetry Surgical, Inc. | 2016-09-07 |
| Fehling-Punches (K153243) | Fehling Instruments GmbH & Co. KG | 2016-08-04 |
| Kerrison Rongeurs (K152734) | Vitalitec Medizintechnik GmbH | 2016-06-18 |
| Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs (K150468) | K2 Medical GmbH & Co. KG | 2016-02-29 |
Recalls involving this device
No recalls on record reference this clearance.