510(k) K133316

SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS) by Epimed International, Inc. — Product Code BSO

K133316 is an FDA 510(k) premarket notification submitted by Epimed International, Inc. for the device "SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)". The FDA issued a decision of Substantially Equivalent on May 28, 2014. The device falls under product code BSO (Catheter, Conduction, Anesthetic), a Class II device regulated under 21 CFR 868.5120. Epimed International, Inc. has at least 10 other 510(k) clearances on record.