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FDA 510(k)

Geister K-Rex rongeurs

K-Number: K242759 · 2025-06-06

ApplicantGeister Medizin Technik GmbH
Decision Date2025-06-06
Product CodeHAE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Geister K-Rex rongeurs is the device name listed in this FDA 510(k) record. The listed applicant is Geister Medizin Technik GmbH. It received FDA 510(k) clearance on 2025-06-06 under 510(k) number K242759. The device is classified under product code HAE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Geister K-Rex rongeurs?

Geister K-Rex rongeurs is a medical device that received FDA 510(k) clearance on 2025-06-06. The listed applicant is Geister Medizin Technik GmbH. The 510(k) number is K242759.

When did Geister K-Rex rongeurs receive FDA 510(k) clearance?

Geister K-Rex rongeurs received FDA 510(k) clearance on 2025-06-06, under 510(k) number K242759.

Who is the listed applicant for Geister K-Rex rongeurs?

The FDA 510(k) record lists Geister Medizin Technik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Geister K-Rex rongeurs?

The FDA product code for Geister K-Rex rongeurs is HAE.

Other records listing Geister Medizin Technik GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K180610Geister retractor for neuro - and spine surgery

Related Devices (Code: HAE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223596SQ.line KERRISONAesculap, Inc.K230256Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AGK221818Rebellion; Phantom Multi-Bite Kerrison RongeurMorpheus AGK210741KLS Martin Neuro RongeursKLS-Martin L.P.K200768Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AGK200387Ace Medical Surgical InstrumentsAce Medical

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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