ClearHemograsper

The ClearHemograsper is a monopolar endoscopic instrument designed to cauterize, coagulate, and perform hemostasis using high-frequency electrical current within the digestive tract. It consists of jaws for grasping bleeding sites, a catheter tube, a slider mechanism, a plug connector, and an irrigation port, available in working lengths from 1650mm to 2300mm.

The device uses monopolar radio frequency current at 2500 Vp (5000 Vp-p) coagulation voltage, has a maximum diameter of 2.8 mm or 3.2 mm, and is constructed from stainless steel and polytetrafluoroethylene. It is sterilized via ethylene oxide with a three-year shelf life and is intended for single use.

Biocompatibility testing per ISO 10993 series (parts 1, 5, 10, 11, 23); sterilization validation per ISO 11135 and ISO 10993-7; electrical safety and EMC per IEC 60601 series (parts 1, 1-2, 2-2, 2-18); packaging stability per ASTM F1980-16, F88/F88M-15, and ISO 11607 series; and performance testing including dimensional, rotational, pushability, tensile strength, hemostatic performance, and temperature assessments.

The device matches the predicate (Olympus Electrosurgical Hemostatic Forceps Series, K062517) in product code, regulation, classification, indications for use, configuration, working length, jaw type, energy modality, biological performance, and electrical safety standards. Although the subject device differs in materials (polytetrafluoroethylene vs. polyethylene), maximum diameter (within 5%), and coagulation voltage (2500 Vp vs. 2900 Vp), the applicant demonstrated through biocompatibility and IEC 60601-2-2 testing that these minor differences do not raise different safety or effectiveness questions.