510(k) K192580

STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device by ETHICON, Inc. — Product Code GAM

K192580 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device". The FDA issued a decision of Substantially Equivalent on December 18, 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.