510(k) K152951

Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray by Paragon Medical, Inc. — Product Code KCT

K152951 is an FDA 510(k) premarket notification submitted by Paragon Medical, Inc. for the device "Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray". The FDA issued a decision of Substantially Equivalent on Dec 28, 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. Paragon Medical, Inc. has 4 other 510(k) clearances on record.