Onepass Endoscopic Vessel Harvesting Sysyetm

K140603 is the FDA 510(k) clearance record for ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETM, a class II device, cleared for Saphena Medical, Inc. on 2014-07-31 under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories). FDA's definition for product code GEI reads: "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available...". FDA records list one 510(k) clearance for Saphena Medical, Inc. As of 2026-09-10, FDA records show one recall naming K140603.