FDA 510(k) Application Details - K221527

Device Classification Name	Suture, Absorbable, Synthetic, Polyglycolic Acid   More FDA Info for this Device
510(K) Number	K221527
Device Name	Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant	Origami Surgical Inc . 42 Main St. Madison, NJ 07940 US Other 510(k) Applications for this Company
Contact	John Gillespie Other 510(k) Applications for this Contact
Regulation Number	878.4493   More FDA Info for this Regulation Number
Classification Product Code	GAM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/26/2022
Decision Date	02/14/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review