FDA 510(k) Application Details - K242759

Device Classification Name	Rongeur, Manual   More FDA Info for this Device
510(K) Number	K242759
Device Name	Rongeur, Manual
Applicant	Geister Medizin Technik GmbH Foehrenstrasse 2 Tuttlingen 78532 DE Other 510(k) Applications for this Company
Contact	Florian Herb Other 510(k) Applications for this Contact
Regulation Number	882.4840   More FDA Info for this Regulation Number
Classification Product Code	HAE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/12/2024
Decision Date	06/06/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review