Home / Device Classification / PLL

PLL — Submucosal Injection Agent Class II

FDA Device Classification

Classification Details

Product Code
PLL
Device Class
Class II
Regulation Number
876.1500
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K241591standard coBlue EyeJuly 3, 2024
K220434standard coBlue Eye (TS-905)August 12, 2022
K221385ovesco endoscopyLiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)August 11, 2022
K200071micro-tech (nanjing) coBlue Beacon Submucosal Injectable SolutionNovember 3, 2020
K202376gi supplyEverLift Submucosal Lifting AgentSeptember 30, 2020
K191923gi supplyEverLift Submucosal Lifting AgentJune 20, 2020
K191254endoclot plus coEndoClotJanuary 30, 2020
K180068boston scientificORISE GelSeptember 28, 2018
K150852cosmo technologiesSIC 8000September 3, 2015