FDA 510(k) Applications Submitted by Stephanie Gorman

FDA 510(k) Number Submission Date Device Name Applicant
K232162 07/21/2023 Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome Boston Scientific Corporation
K202478 08/28/2020 Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares Boston Scientific Corporation


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