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)

EndoClot

K-Number: K191254 · 2020-01-30

ApplicantEndoclot Plus Co., Ltd.
Decision Date2020-01-30
Product CodePLL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EndoClot is a medical device manufactured by Endoclot Plus Co., Ltd.. It received FDA 510(k) clearance on 2020-01-30 under approval 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. It is manufactured by Endoclot Plus Co., Ltd.. The 510(k) number is K191254.

When was EndoClot approved by the FDA?

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

What company makes EndoClot?

EndoClot is manufactured by Endoclot Plus Co., Ltd..

What is the FDA product code for EndoClot?

The FDA product code for EndoClot is PLL.

Other Devices by Endoclot Plus Co., Ltd.

K162197EndoClot K190677EndoClot

Related Devices (Code: PLL)

K180068ORISE GelBoston Scientific K200071Blue Beacon Submucosal Injectable SolutionMicro-Tech (Nanjing) Co., Ltd. K202376EverLift Submucosal Lifting AgentGi Supply, Inc. K191923EverLift Submucosal Lifting AgentGi Supply 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.

↑