Rebellion; Phantom Multi-Bite Kerrison Rongeur
FDA 510(k) K221818 · Morpheus AG
510(k) numberK221818
Submission
- Device name
- Rebellion; Phantom Multi-Bite Kerrison Rongeur
- Applicant
- Morpheus AG
Spaichingen, DE - Received
- June 23, 2022
- Decision date
- October 7, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K153243 | Fehling-PunchesHAE · Traditional | Fehling Instruments GmbH & Co. KG | 08/04/2016SE |
More from Fehling Instruments GmbH & Co. KG
Questions and answers
When was Rebellion; Phantom Multi-Bite Kerrison Rongeur cleared by the FDA?
Rebellion; Phantom Multi-Bite Kerrison Rongeur (K221818) received a 510(k) decision of Substantially Equivalent on October 7, 2022, 106 days after the submission was received.
What is the product code of K221818?
The FDA product code is HAE – Rongeur, Manual, a Class II (moderate risk) device regulated under 21 CFR 882.4840.