FDA 510(k), K180068, ORISE Gel

510(K) Number: K180068
Device Name: ORISE Gel
Manufacturer: Boston Scientific
Device Classification Name: submucosal injection agent
Regulation Number: 876.1500
Classification Product Code: PLL
Date Received: 01/09/2018
Decision Date: 09/28/2018
Regulation Medical Specialty: Gastroenterology/Urology

197 pages (1,892 of 2,089 original pages are fully redacted)