510(k) K134026

ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT by Olympus Medical Systems Corp. — Product Code PGU

K134026 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT". The FDA issued a decision of Substantially Equivalent on March 7, 2014. The device falls under product code PGU (Spatial Imaging For Display Of Endoscope Position), a Class II device regulated under 21 CFR 876.1500. Olympus Medical Systems Corp. has at least 10 other 510(k) clearances on record.