FDA 510(k)

Disposable hemoclip

K-Number: K213217 · 2022-11-14

ApplicantBeijing Zksk Technology Co., Ltd.

Decision Date2022-11-14

Product CodePKL

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Disposable hemoclip is a medical device manufactured by Beijing Zksk Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-11-14 under approval number K213217. 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 Disposable hemoclip?

Disposable hemoclip is a medical device that received FDA 510(k) clearance on 2022-11-14. It is manufactured by Beijing Zksk Technology Co., Ltd.. The 510(k) number is K213217.

When was Disposable hemoclip approved by the FDA?

Disposable hemoclip received FDA 510(k) clearance on 2022-11-14, under approval number K213217.

What company makes Disposable hemoclip?

Disposable hemoclip is manufactured by Beijing Zksk Technology Co., Ltd..

What is the FDA product code for Disposable hemoclip?

The FDA product code for Disposable hemoclip is PKL.

Other Devices by Beijing Zksk Technology Co., Ltd.

K213222Disposable Polypectomy Snare K213223Multi-Band Ligator K213239Endoscopic Injection Needle K231721Disposable Hot Biopsy Forceps K242192Disposable Sphincterotome

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

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