ClearEndoclip
K-Number: K183021 · 2019-06-28
ApplicantFinemedix Co., Ltd.
Decision Date2019-06-28
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
ClearEndoclip is a medical device manufactured by Finemedix Co., Ltd.. It received FDA 510(k) clearance on 2019-06-28 under approval number K183021. The device is classified under product code PKL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ClearEndoclip?
ClearEndoclip is a medical device that received FDA 510(k) clearance on 2019-06-28. It is manufactured by Finemedix Co., Ltd.. The 510(k) number is K183021.
When was ClearEndoclip approved by the FDA?
ClearEndoclip received FDA 510(k) clearance on 2019-06-28, under approval number K183021.
What company makes ClearEndoclip?
ClearEndoclip is manufactured by Finemedix Co., Ltd..
What is the FDA product code for ClearEndoclip?
The FDA product code for ClearEndoclip is PKL.
Other Devices by Finemedix Co., Ltd.
Related Devices (Code: PKL)
K153550FTRD System SetOvesco Endoscopy AG
K170867FTRD System SetOvesco Endoscopy AG
K161463SureClip(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.
K182556SureClip Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.
K180325Single Use MultiClip DeviceMicro-Tech (Nanjing) Co., Ltd.
K172727HemoclipHangzhou AGS MedTech 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.