510(k) K100273

INSTAFLO BOWEL CATHETER SYSTEM KIT by Hollister, Inc. — Product Code KNT

K100273 is an FDA 510(k) premarket notification submitted by Hollister, Inc. for the device "INSTAFLO BOWEL CATHETER SYSTEM KIT". The FDA issued a decision of Substantially Equivalent (kit) on April 22, 2010. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Hollister, Inc. has at least 10 other 510(k) clearances on record.