510(k) K151166

Instru-Safe Instrument Protection System by Summit Medical, Inc. — Product Code KCT

K151166 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 August 18, 2015. 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.