510(k) K991223

ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC by Aesculap, Inc. — Product Code GAL

K991223 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC". The FDA issued a decision of Substantially Equivalent on April 30, 1999. The device falls under product code GAL (Suture, Absorbable, Natural), a Class II device regulated under 21 CFR 878.4830. Aesculap, Inc. has at least 10 other 510(k) clearances on record.