Cleared Traditional

Geister K-Rex rongeurs

K242759 · Geister Medizin Technik GmbH · Neurology
Jun 2025
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K242759 is an FDA 510(k) clearance for the Geister K-Rex rongeurs, 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 review panel. Regulated under 21 CFR 882.4840.

Submission Details

510(k) Number K242759 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code HAE — Rongeur, Manual
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4840

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