FDA.report

510(k) K242759

Device
Geister K-Rex rongeurs
Applicant
Geister Medizin Technik GmbH
510(k) number
K242759
Product code
HAE
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-06
Date received
2024-09-12
Regulation
882.4840
Classification name
Rongeur, Manual
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Florian Herb
Address
Foehrenstrasse 2 Tuttlingen DE 78532 78532

FDA Registration Numbers

Source Documents

510(k) summary PDF

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