J & J ’ s Ethicon wins FDA nod for Echelon Flex 45mm GST

Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said today it won FDA 510(k) clearance for its Echelon Flex 45mm endocutter with proprietary gripping surface technology. The clearance follows an earlier pass by the federal agency for Ethicon’s Echelon Flex 60mm powered plus stapler. With the new clearance, Echelon’s Flex GST system offers both 45mm and 60mm endocutters with exclusive reloads. “Ethicon is committed to bringing innovative products to market that are designed to reduce complications in the most challenging oncology and metabolic surgical cases. The Echelon Flex GST system controls tissue movement with pre-compression and gripping surface technology, which is 7 times more likely to completely capture mucosa in the staple line vs. the other leading endocutter on the market, optimizing tissue for healing,” global endomechanical platform leader VP Tom O’Brien said in a press release. Ethicon said its Echelon Flex GST system is designed to control tissue movement to ensure more accurate transections, and that its newly cleared model included improvements across several specialties including thoracic, colorectal and bariatric. Earlier this month, Ethicon Endo-Surgery said that it paid an unspecified amount to purchase Megadyne Medical Products, 4 years after inking a collaboration deal with the electrosurgical tools maker . Back in 2013, the companies joined forces to market a combined portfolio of energy-based surgical devicesÂ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: 510(k) Regulatory/Compliance Surgical Ethicon Johnson & Johnson Source Type: news