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FDA 510(k)

Single Use Rotatable and Repositionable Hemoclip

K-Number: K201771 · 2020-10-19

ApplicantAnrei Medical (Hangzhou) Co., Ltd.
Decision Date2020-10-19
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single Use Rotatable and Repositionable Hemoclip is a medical device manufactured by Anrei Medical (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2020-10-19 under approval number K201771. 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 Single Use Rotatable and Repositionable Hemoclip?

Single Use Rotatable and Repositionable Hemoclip is a medical device that received FDA 510(k) clearance on 2020-10-19. It is manufactured by Anrei Medical (Hangzhou) Co., Ltd.. The 510(k) number is K201771.

When was Single Use Rotatable and Repositionable Hemoclip approved by the FDA?

Single Use Rotatable and Repositionable Hemoclip received FDA 510(k) clearance on 2020-10-19, under approval number K201771.

What company makes Single Use Rotatable and Repositionable Hemoclip?

Single Use Rotatable and Repositionable Hemoclip is manufactured by Anrei Medical (Hangzhou) Co., Ltd..

What is the FDA product code for Single Use Rotatable and Repositionable Hemoclip?

The FDA product code for Single Use Rotatable and Repositionable Hemoclip is PKL.

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Other Devices by Anrei Medical (Hangzhou) Co., Ltd.

K192048Single Use Endoscope Valves Set K210917Single Use Injection Needle K202987Rescue Pulmonary Grasping Forceps K210660Stone Retrieval Balloon Catheter K212999Multi-Functional Electrosurgical Knife

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.

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