Cleared Traditional

LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)

K221385 · Ovesco Endoscopy AG · Gastroenterology & Urology

Aug 2022

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K221385 is an FDA 510(k) clearance for the LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02), a Submucosal Injection Agent (Class II — Special Controls, product code PLL), submitted by Ovesco Endoscopy AG (Tuebingen, DE). The FDA issued a Cleared decision on August 11, 2022, 90 days after receiving the submission on May 13, 2022. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K221385 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 13, 2022
Decision Date	August 11, 2022
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement

Device Classification

Product Code	PLL — Submucosal Injection Agent
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
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.