K242759 is an FDA 510(k) clearance for the Geister K-Rex rongeurs. This device is classified as a Rongeur, Manual (Class II - Special Controls, product code HAE).
Submitted by Geister Medizin Technik GmbH (Tuttlingen, DE). The FDA issued a Cleared decision on June 6, 2025, 267 days after receiving the submission on September 12, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4840.
| 510(k) Number | K242759 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2024 |
| Decision Date | June 06, 2025 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HAE - Rongeur, Manual |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4840 |