Geister K-Rex rongeurs
FDA 510(k) K242759 · Geister Medizin Technik GmbH
510(k) numberK242759
Submission
- Device name
- Geister K-Rex rongeurs
- Applicant
- Geister Medizin Technik GmbH
Tuttlingen, DE - Received
- September 12, 2024
- Decision date
- June 6, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K210741 | KLS Martin Neuro RongeursHAE · Traditional | KLS-Martin L.P. | 06/03/2022SE |
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| K180610 | Geister retractor for neuro - and spine surgeryGZT · Traditional | 08/29/2018SE |
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| K982365 | Atraumatic Vascular Clamps, Model #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX Micro Vascular…DXC · Traditional | 04/08/1999SE |
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Questions and answers
When was Geister K-Rex rongeurs cleared by the FDA?
Geister K-Rex rongeurs (K242759) received a 510(k) decision of Substantially Equivalent on June 6, 2025, 267 days after the submission was received.
What is the product code of K242759?
The FDA product code is HAE – Rongeur, Manual, a Class II (moderate risk) device regulated under 21 CFR 882.4840.