FDA 510(k), K191254, EndoClot

510(K) Number: K191254
Device Name: EndoClot
Manufacturer: EndoClot Plus Co., Ltd.
Device Classification Name: submucosal injection agent
Regulation Number: 876.1500
Classification Product Code: PLL
Date Received: 05/10/2019
Decision Date: 01/30/2020
Regulation Medical Specialty: Gastroenterology/Urology

246 pages (1,034 of 1,280 original pages are fully redacted)