510(k) K130843

SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE by Oscor, Inc. — Product Code DRC

K130843 is an FDA 510(k) premarket notification submitted by Oscor, Inc. for the device "SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE". The FDA issued a decision of Substantially Equivalent on January 8, 2014. The device falls under product code DRC (Trocar), a Class II device regulated under 21 CFR 870.1390. Oscor, Inc. has at least 10 other 510(k) clearances on record.