FDA 510(k) Applications for Medical Device Product Code "PLL"

FDA 510(k) Number Applicant Device Name Decision Date
K180068 Boston Scientific ORISE Gel 09/28/2018
K150852 COSMO TECHNOLOGIES, LTD. SIC 8000 09/03/2015
K191254 EndoClot Plus Co., Ltd. EndoClot 01/30/2020
K191923 GI Supply EverLift Submucosal Lifting Agent 06/20/2020
K202376 Gi Supply, Inc. EverLift Submucosal Lifting Agent 09/30/2020
K200071 Micro-Tech (Nanjing) Co., Ltd. Blue Beacon Submucosal Injectable Solution 11/03/2020
K221385 Ovesco Endoscopy AG LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) 08/11/2022
K220434 The Standard Co., Ltd. Blue Eye (TS-905) 08/12/2022


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