FDA 510(k) Application Details - K241872

Device Classification Name	More FDA Info for this Device
510(K) Number	K241872
Device Name	Remanufactured EndoWrist ProGrasp Forceps (420093)
Applicant	Rebotix 539 Pasadena Avenue South St. Petersburg, FL 33707 US Other 510(k) Applications for this Company
Contact	Chris Gibson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/2024
Decision Date	11/07/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review