EverLift Submucosal Lifting Agent— 510(k) K191923

Substantially Equivalent

Gi Supply

FDA 510(k) clearance K191923 for EverLift Submucosal Lifting Agent, Substantially Equivalent on 2020-06-20. Applicant: Gi Supply. Device class: 2.

Clearance details

Applicant: Gi Supply
Product code: Code PLL
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2019-07-18
Decision date: 2020-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mechanicsburg, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PLL

K260997 — SIS BLU (SISBLU-30-01); SIS BLU (SISBLU-15-01)2026-09-09
K241591 — Blue Eye2024-07-03
K220434 — Blue Eye (TS-905)2022-08-12
K221385 — LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)2022-08-11
K200071 — Blue Beacon Submucosal Injectable Solution2020-11-03

More clearances from Gi Supply

K031360 — GI SUPPLY BILIARY STENT2003-09-24
K012411 — HP-ONE2001-09-25
K970186 — GI SUPPLY PARACENTESIS PUMP1997-02-14
K970187 — RUNYON LARGE VOLUME PARACENTESIS KIT1997-02-14
K944903 — HP-FAST1995-04-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.