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Power Medical files special 510(k) for vascular stapler

 
• By Elizabeth Cairns

Power Medical Interventions (PMI) has submitted a special premarket notification to the US FDA, requesting clearance of its i45V Intelligent Surgical Instrument and 45mm reload cartridge. The i45V is a reusable, autoclavable linear stapler designed for use in endoscopic surgery and natural orifice translumenal endoscopic surgery (NOTES). Also known as a Special 510(k), the submission – if granted – will allow the marketing of a modified form of the device for transection and occlusion of vascular structures. The FDA generally processes Special 510(k)s within 30 days of receipt, PMI, of Langhorne, Pennsylvania, said. The i45V is part of PMI's Intelligent Surgical Instruments product line: computer-assisted endomechanical instruments used for cutting, stapling and tissue manipulation in both open and keyhole surgery. The firm claims that the device has potential in minimally-invasive gynaecological, urologic, thoracic, colonic, rectal and general surgery.

Power Medical Interventions (PMI) has submitted a special premarket notification to the US FDA, requesting clearance of its i45V Intelligent Surgical Instrument and 45mm reload cartridge. The i45V is a reusable, autoclavable linear stapler designed for use in endoscopic surgery and natural orifice translumenal endoscopic surgery (NOTES). Also known as a Special 510(k), the submission – if granted – will allow the marketing of a modified form of the device for transection and occlusion of vascular structures. The FDA generally processes Special 510(k)s within 30 days of receipt, PMI, of Langhorne, Pennsylvania, said. The i45V is part of PMI's Intelligent Surgical Instruments product line: computer-assisted endomechanical instruments used for cutting, stapling and tissue manipulation in both open and keyhole surgery. The firm claims that the device has potential in minimally-invasive gynaecological, urologic, thoracic, colonic, rectal and general surgery.

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