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FDA 510(k)

EverLift Submucosal Lifting Agent

K-Number: K202376 · 2020-09-30

ApplicantGi Supply, Inc.
Decision Date2020-09-30
Product CodePLL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EverLift Submucosal Lifting Agent is the device name listed in this FDA 510(k) record. The listed applicant is Gi Supply, Inc.. It received FDA 510(k) clearance on 2020-09-30 under 510(k) number K202376. 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 2020-09-30. The listed applicant is Gi Supply, Inc.. The 510(k) number is K202376.

When did EverLift Submucosal Lifting Agent receive FDA 510(k) clearance?

EverLift Submucosal Lifting Agent received FDA 510(k) clearance on 2020-09-30, under 510(k) number K202376.

Who is the listed applicant for EverLift Submucosal Lifting Agent?

The FDA 510(k) record lists Gi Supply, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Gi Supply, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221042Renova RP Centesis PumpK191923EverLift Submucosal Lifting Agent

Related Devices (Code: PLL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241591Blue EyeThe Standard 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 AGK200071Blue Beacon Submucosal Injectable SolutionMicro-Tech (Nanjing) Co., Ltd.K191923EverLift Submucosal Lifting AgentGi SupplyK191254EndoClotEndoclot Plus Co., Ltd.

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.

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