510(k) K140289

INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM by Summit Medical, Inc. — Product Code KCT

K140289 is an FDA 510(k) premarket notification submitted by Summit Medical, Inc. for the device "INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM". The FDA issued a decision of Substantially Equivalent on June 27, 2014. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Summit Medical, Inc. has at least 10 other 510(k) clearances on record.