510(k) K072216

KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536 by Kapp Surgical Instrument, Inc. — Product Code NEU

K072216 is an FDA 510(k) premarket notification submitted by Kapp Surgical Instrument, Inc. for the device "KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536". The FDA issued a decision of Substantially Equivalent on November 9, 2007. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Kapp Surgical Instrument, Inc. has at least 8 other 510(k) clearances on record.