FDA 510(k) Application Details - K242201

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K242201
Device Name	Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant	Threadstone LLC 1035 Benfield Blvd Suite H Millersville, MD 21108 US Other 510(k) Applications for this Company
Contact	Jeremy Clark Other 510(k) Applications for this Contact
Regulation Number	878.5000   More FDA Info for this Regulation Number
Classification Product Code	GAT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/26/2024
Decision Date	03/27/2025
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