Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EverLift Submucosal Lifting Agent

K-Number: K191923 · 2020-06-20

ApplicantGi Supply
Decision Date2020-06-20
Product CodePLL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EverLift Submucosal Lifting Agent is a medical device manufactured by Gi Supply. It received FDA 510(k) clearance on 2020-06-20 under approval number K191923. The device is classified under product code PLL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EverLift Submucosal Lifting Agent?

EverLift Submucosal Lifting Agent is a medical device that received FDA 510(k) clearance on 2020-06-20. It is manufactured by Gi Supply. The 510(k) number is K191923.

When was EverLift Submucosal Lifting Agent approved by the FDA?

EverLift Submucosal Lifting Agent received FDA 510(k) clearance on 2020-06-20, under approval number K191923.

What company makes EverLift Submucosal Lifting Agent?

EverLift Submucosal Lifting Agent is manufactured by Gi Supply.

What is the FDA product code for EverLift Submucosal Lifting Agent?

The FDA product code for EverLift Submucosal Lifting Agent is PLL.

Related Devices (Code: PLL)

K180068ORISE GelBoston Scientific K200071Blue Beacon Submucosal Injectable SolutionMicro-Tech (Nanjing) Co., Ltd. K202376EverLift Submucosal Lifting AgentGi Supply, Inc. K191254EndoClotEndoclot Plus Co., Ltd. K220434Blue Eye (TS-905)The Standard Co., Ltd. K221385LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)Ovesco Endoscopy AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑