FDA 510(k)

Hemoclip

K-Number: K211787 · 2022-03-03

Decision Date2022-03-03

Product CodePKL

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Hemoclip is a medical device manufactured by Hangzhou AGS MedTech Co., Ltd.. It received FDA 510(k) clearance on 2022-03-03 under approval number K211787. 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 Hemoclip?

Hemoclip is a medical device that received FDA 510(k) clearance on 2022-03-03. It is manufactured by Hangzhou AGS MedTech Co., Ltd.. The 510(k) number is K211787.

When was Hemoclip approved by the FDA?

Hemoclip received FDA 510(k) clearance on 2022-03-03, under approval number K211787.

What company makes Hemoclip?

Hemoclip is manufactured by Hangzhou AGS MedTech Co., Ltd..

What is the FDA product code for Hemoclip?

The FDA product code for Hemoclip is PKL.

Other Devices by Hangzhou AGS MedTech Co., Ltd.

K172729Polypectomy Snare K172727Hemoclip K202237Locking device K201509Disposable Stone Extraction basket K192342Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories) K200173Stone Retrieval Balloon

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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.