510(k) K242208

PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) by Primed Medical Products, Inc. — Product Code FRG

K242208 is an FDA 510(k) premarket notification submitted by Primed Medical Products, Inc. for the device "PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)". The FDA issued a decision of Substantially Equivalent on October 7, 2024. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Primed Medical Products, Inc. has at least 7 other 510(k) clearances on record.