510(k) K220219

PERMALOOP Suture, PERMATAPE Suture by Medos International SARL — Product Code GAT

K220219 is an FDA 510(k) premarket notification submitted by Medos International SARL for the device "PERMALOOP Suture, PERMATAPE Suture". The FDA issued a decision of Substantially Equivalent on April 26, 2022. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Medos International SARL has at least 10 other 510(k) clearances on record.