Rongeur (Neurosurgical Instruments)
FDA 510(k) K875043 · Solway, Inc.
510(k) numberK875043
Submission
- Device name
- Rongeur (Neurosurgical Instruments)
- Applicant
- Solway, Inc.
Hollywood, FL, US - Received
- December 2, 1987
- Decision date
- January 22, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code HAE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242759 | Geister K-Rex rongeursHAE · Traditional | Geister Medizin Technik GmbH | 06/06/2025SE |
| K223596 | SQ.line KERRISONHAE · Traditional | Aesculap, Inc. | 06/29/2023SE |
| K230256 | Rebellion, Phantom Multi-Bite Kerrison RongeurHAE · Special | Morpheus AG | 03/03/2023SE |
| K221818 | Rebellion; Phantom Multi-Bite Kerrison RongeurHAE · Special | Morpheus AG | 10/07/2022SE |
| K210741 | KLS Martin Neuro RongeursHAE · Traditional | KLS-Martin L.P. | 06/03/2022SE |
| K200768 | Rebellion, Phantom Multi-Bite Kerrison RongeurHAE · Traditional | Morpheus AG | 05/04/2021SE |
| K200387 | Ace Medical Surgical InstrumentsHAE · Traditional | Ace Medical | 07/21/2020SE |
| K200383 | Wiggins Medical Surgical InstrumentsHAE · Traditional | Wiggins Medical | 07/21/2020SE |
| K180949 | SteribiteHAE · Traditional | Rjr Surgical, Inc. | 11/08/2018SE |
| K161744 | Symmetry Sharp Kerrison RongeurHAE · Special | Symmetry Surgical, Inc. | 09/07/2016SE |
More from Symmetry Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K874960 | Cardiovascular Surgical InstrumentsDWS · Traditional | 02/05/1988SE |
| K874962 | Forceps Cliprack Ventricular Cannula Saws SpatulasHAO · Traditional | 02/02/1988SE |
| K874956 | Self-Retaining Retractor for NeurosurgeryGZT · Traditional | 01/28/1988SE |
| K874964 | Dental Hand InstrumentsEKJ · Traditional | 01/27/1988SE |
| K874966 | Tuning ForksGWX · Traditional | 01/04/1988SE |
| K874965 | Manual Surgical Instruments for General UseHTD · Traditional | 12/30/1987SE |
| K874961 | Bone Cutting Instruments & AccessoriesGDR · Traditional | 12/30/1987SE |
| K874959 | Vascular ClampHXD · Traditional | 12/30/1987SE |
| K874954 | Manual RongeurHTX · Traditional | 12/30/1987SE |
| K874952 | Manual Cranial Drill, Burr, Trephine & AccessoriesHBG · Traditional | 12/30/1987SE |
Questions and answers
When was Rongeur (Neurosurgical Instruments) cleared by the FDA?
Rongeur (Neurosurgical Instruments) (K875043) received a 510(k) decision of Substantially Equivalent on January 22, 1988, 51 days after the submission was received.
What is the product code of K875043?
The FDA product code is HAE – Rongeur, Manual, a Class II (moderate risk) device regulated under 21 CFR 882.4840.