FDA 510(k)

EndoClot

K-Number: K191254 · 2020-01-30

Decision Date2020-01-30

Product CodePLL

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

EndoClot is the device name listed in this FDA 510(k) record. The listed applicant is Endoclot Plus Co., Ltd.. It received FDA 510(k) clearance on 2020-01-30 under 510(k) number K191254. 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 EndoClot?

EndoClot is a medical device that received FDA 510(k) clearance on 2020-01-30. The listed applicant is Endoclot Plus Co., Ltd.. The 510(k) number is K191254.

When did EndoClot receive FDA 510(k) clearance?

EndoClot received FDA 510(k) clearance on 2020-01-30, under 510(k) number K191254.

Who is the listed applicant for EndoClot?

The FDA 510(k) record lists Endoclot Plus Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EndoClot?

The FDA product code for EndoClot is PLL.

Other records listing Endoclot Plus Co., Ltd. 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.

K190677EndoClot K162197EndoClot

Related Devices (Code: PLL)

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 AG K200071Blue Beacon Submucosal Injectable SolutionMicro-Tech (Nanjing) Co., Ltd.K202376EverLift Submucosal Lifting AgentGi Supply, Inc.K191923EverLift Submucosal Lifting AgentGi Supply

Official Source

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