510(k) K183183

VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture by ETHICON, Inc. — Product Code GAM

K183183 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture". The FDA issued a decision of Substantially Equivalent on June 27, 2019. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. ETHICON, Inc. has at least 10 other 510(k) clearances on record.