510(k) K221385

LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) by Ovesco Endoscopy AG — Product Code PLL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 11, 2022
Date Received: May 13, 2022
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Submucosal Injection Agent
Device Class: Class II
Regulation Number: 876.1500
Review Panel: GU
Submission Type

Intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.

Other clearances by Ovesco Endoscopy AG

K251562 — OTSCneo System Set (100.03n-14n, 100.27n-31n) (December 18, 2025)
K242586 — ArgoCap (200.52) (May 22, 2025)
K241858 — BARS Set (100.60) (August 26, 2024)
K200684 — gastroduodenal FTRD Set (June 2, 2020)
K183309 — stentfix OTSC System Set (October 22, 2019)
DEN160014 — remOVE System (December 22, 2017)
K170867 — FTRD System Set (July 25, 2017)
K153550 — FTRD System Set (October 12, 2016)
K150067 — OTSC Proctology (September 16, 2015)
K141790 — AQANIFE (March 6, 2015)

Other clearances for product code PLL

K241591 — Blue Eye (July 3, 2024)
K220434 — Blue Eye (TS-905) (August 12, 2022)
K200071 — Blue Beacon Submucosal Injectable Solution (November 3, 2020)
K202376 — EverLift Submucosal Lifting Agent (September 30, 2020)
K191923 — EverLift Submucosal Lifting Agent (June 20, 2020)
K191254 — EndoClot (January 30, 2020)
K180068 — ORISE Gel (September 28, 2018)
K150852 — SIC 8000 (September 3, 2015)