510(k) K100593

SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME by Lsi Solutions, Inc. — Product Code GAW

K100593 is an FDA 510(k) premarket notification submitted by Lsi Solutions, Inc. for the device "SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME". The FDA issued a decision of Substantially Equivalent on October 13, 2010. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Lsi Solutions, Inc. has at least 10 other 510(k) clearances on record.