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510(k) K221385

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

K221385 is an FDA 510(k) premarket notification submitted by Ovesco Endoscopy AG for the device "LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)". The FDA issued a decision of Substantially Equivalent on August 11, 2022. The device falls under product code PLL (Submucosal Injection Agent), a Class II device regulated under 21 CFR 876.1500. Ovesco Endoscopy AG has at least 10 other 510(k) clearances on record.

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)

FDA data resources