FDA 510(k) Application Details - K233312

Device Classification Name	More FDA Info for this Device
510(K) Number	K233312
Device Name	SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894
Applicant	AKTORmed GmbH Neugablonzer Strasse 13 Neutraubling 93073 DE Other 510(k) Applications for this Company
Contact	Hanna Kafurke Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QZB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2023
Decision Date	08/08/2024
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