FDA 510(k) Application Details - K220454

Device Classification Name	Stimulator,Peripheral Nerve,Non-Implanted,For Pelvic Floor Dysfunction   More FDA Info for this Device
510(K) Number	K220454
Device Name	Stimulator,Peripheral Nerve,Non-Implanted,For Pelvic Floor Dysfunction
Applicant	Avation Medical, Inc. 1375 Perry St Columbus, OH 43201 US Other 510(k) Applications for this Company
Contact	Manish Vaishya Other 510(k) Applications for this Contact
Regulation Number	876.5310   More FDA Info for this Regulation Number
Classification Product Code	NAM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/17/2022
Decision Date	04/03/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review