510(k) K173874

StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO by Origami Surgical, LLC — Product Code GAM

K173874 is an FDA 510(k) premarket notification submitted by Origami Surgical, LLC for the device "StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO". The FDA issued a decision of Substantially Equivalent on May 4, 2018. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Origami Surgical, LLC has at least 6 other 510(k) clearances on record.