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BioWorld - Monday, February 9, 2026
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Home » Interscope receives FDA de novo marketing authorization for direct endoscopic necrosectomy, inks Micro-Tech Endoscopy agreement
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Interscope receives FDA de novo marketing authorization for direct endoscopic necrosectomy, inks Micro-Tech Endoscopy agreement

Dec. 30, 2020
By Anette Breindl
The U.S. FDA granted de novo marketing authorization to Interscope Inc.’s Endorotor system for direct endoscopic necrosectomy (DEN) of walled-off pancreatic necrosis, giving the specialty device a cutting edge over more generic tools often used for the challenging procedure. Endorotor received a CE mark for this indication in 2018 and also has FDA 510(k) clearance for post-endoscopic mucosal resection tissue persistence with a scarred base and for removal of endobronchial tumors and granulation tissue.
Medical technology Regulatory Gastrointestinal De novo FDA

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