510(k) K810007

PENTAX UPPER G.I. FIBERSCOPE, #FG-34 by Pentax Precision Instrument Corp. — Product Code GDB

K810007 is an FDA 510(k) premarket notification submitted by Pentax Precision Instrument Corp. for the device "PENTAX UPPER G.I. FIBERSCOPE, #FG-34". The FDA issued a decision of Substantially Equivalent on January 15, 1981. The device falls under product code GDB (Endoscope, Fiber Optic), a Class II device regulated under 21 CFR 876.1500. Pentax Precision Instrument Corp. has at least 10 other 510(k) clearances on record.