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FDA 510(k)

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

K-Number: K221385 · 2022-08-11

ApplicantOvesco Endoscopy AG
Decision Date2022-08-11
Product CodePLL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) is the device name listed in this FDA 510(k) record. The listed applicant is Ovesco Endoscopy AG. It received FDA 510(k) clearance on 2022-08-11 under 510(k) number K221385. 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 LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)?

LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) is a medical device that received FDA 510(k) clearance on 2022-08-11. The listed applicant is Ovesco Endoscopy AG. The 510(k) number is K221385.

When did LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) receive FDA 510(k) clearance?

LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) received FDA 510(k) clearance on 2022-08-11, under 510(k) number K221385.

Who is the listed applicant for LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)?

The FDA 510(k) record lists Ovesco Endoscopy AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)?

The FDA product code for LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) is PLL.

Other records listing Ovesco Endoscopy AG as applicant

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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.K200071Blue Beacon Submucosal Injectable SolutionMicro-Tech (Nanjing) Co., Ltd.K202376EverLift Submucosal Lifting AgentGi Supply, Inc.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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