510(k) K951448

GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE by Global Medical Products, Ltd. — Product Code DRC

K951448 is an FDA 510(k) premarket notification submitted by Global Medical Products, Ltd. for the device "GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE". The FDA issued a decision of Substantially Equivalent on March 27, 1996. The device falls under product code DRC (Trocar), a Class II device regulated under 21 CFR 870.1390. Global Medical Products, Ltd. has at least 5 other 510(k) clearances on record.