510(k) K974312

REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR by Telemed Systems, Inc. — Product Code KNW

K974312 is an FDA 510(k) premarket notification submitted by Telemed Systems, Inc. for the device "REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR". The FDA issued a decision of Substantially Equivalent on January 21, 1998. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Telemed Systems, Inc. has at least 10 other 510(k) clearances on record.