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510(k) K191923

EverLift Submucosal Lifting Agent by Gi Supply — Product Code PLL

K191923 is an FDA 510(k) premarket notification submitted by Gi Supply for the device "EverLift Submucosal Lifting Agent". The FDA issued a decision of Substantially Equivalent on June 20, 2020. The device falls under product code PLL (Submucosal Injection Agent), a Class II device regulated under 21 CFR 876.1500. Gi Supply has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2020
Date Received
July 18, 2019
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 Gi Supply

  • K221042 — Renova RP Centesis Pump (April 19, 2023)
  • K202376 — EverLift Submucosal Lifting Agent (September 30, 2020)
  • K031360 — GI SUPPLY BILIARY STENT (September 24, 2003)
  • K012411 — HP-ONE (September 25, 2001)
  • K970186 — GI SUPPLY PARACENTESIS PUMP (February 14, 1997)
  • K970187 — RUNYON LARGE VOLUME PARACENTESIS KIT (February 14, 1997)
  • K944903 — HP-FAST (April 20, 1995)
  • K931044 — OXY-BLOC (October 4, 1993)
  • K915816 — BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY (March 27, 1992)

Other clearances for product code PLL

  • K241591 — Blue Eye (July 3, 2024)
  • K220434 — Blue Eye (TS-905) (August 12, 2022)
  • K221385 — LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) (August 11, 2022)
  • K200071 — Blue Beacon Submucosal Injectable Solution (November 3, 2020)
  • K202376 — EverLift Submucosal Lifting Agent (September 30, 2020)
  • K191254 — EndoClot (January 30, 2020)
  • K180068 — ORISE Gel (September 28, 2018)
  • K150852 — SIC 8000 (September 3, 2015)

FDA data resources