FDA 510(k) Application Details - K243233

Device Classification Name	More FDA Info for this Device
510(K) Number	K243233
Device Name	esolution« Esophageal Retractor
Applicant	S4 Medical Corp. 34 South Main Street, Suite 200 Chagrin Falls, OH 44022 US Other 510(k) Applications for this Company
Contact	William Fuller Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QXU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/09/2024
Decision Date	11/09/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review