FDA 510(k) Application Details - K240831

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K240831
Device Name	Laparoscope, General & Plastic Surgery
Applicant	Asclepion Laser Technologies GmbH Bruesseler Strasse 10 Jena 07745 DE Other 510(k) Applications for this Company
Contact	Tom Gruender Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	GCJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/2024
Decision Date	11/06/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review