SQ.line KERRISON
FDA 510(k) K223596 · Aesculap, Inc.
510(k) numberK223596
Submission
- Device name
- SQ.line KERRISON
- Applicant
- Aesculap, Inc.
Center Valley, PA, US - Received
- December 2, 2022
- Decision date
- June 29, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K242759 | Geister K-Rex rongeursHAE · Traditional | Geister Medizin Technik GmbH | 06/06/2025SE |
| 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 |
| K153243 | Fehling-PunchesHAE · Traditional | Fehling Instruments GmbH & Co. KG | 08/04/2016SE |
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| K203461 | Aesculap Caiman 12 Seal and Cut Technology SystemGEI · Special | 12/18/2020SE |
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Questions and answers
When was SQ.line KERRISON cleared by the FDA?
SQ.line KERRISON (K223596) received a 510(k) decision of Substantially Equivalent on June 29, 2023, 209 days after the submission was received.
What is the product code of K223596?
The FDA product code is HAE – Rongeur, Manual, a Class II (moderate risk) device regulated under 21 CFR 882.4840.