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FDA 510(k)

SureClip(TM) Repositionable Hemostasis Clip

K-Number: K161463 · 2017-01-06

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2017-01-06
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SureClip(TM) Repositionable Hemostasis Clip is a medical device manufactured by Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2017-01-06 under approval number K161463. 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 SureClip(TM) Repositionable Hemostasis Clip?

SureClip(TM) Repositionable Hemostasis Clip is a medical device that received FDA 510(k) clearance on 2017-01-06. It is manufactured by Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K161463.

When was SureClip(TM) Repositionable Hemostasis Clip approved by the FDA?

SureClip(TM) Repositionable Hemostasis Clip received FDA 510(k) clearance on 2017-01-06, under approval number K161463.

What company makes SureClip(TM) Repositionable Hemostasis Clip?

SureClip(TM) Repositionable Hemostasis Clip is manufactured by Micro-Tech (Nanjing) Co., Ltd..

What is the FDA product code for SureClip(TM) Repositionable Hemostasis Clip?

The FDA product code for SureClip(TM) Repositionable Hemostasis Clip is PKL.

Other Devices by Micro-Tech (Nanjing) Co., Ltd.

K162466LuminScan (TM) Imaging System K160625Disposable Hot Biopsy Forceps K152802Grasping Forceps K172309Endoscopic Ultrasound Aspiration Needle K162226Reliant Multistage Dilatation Balloon Catheter K182556SureClip Repositionable Hemostasis Clip

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Related Devices (Code: PKL)

K153550FTRD System SetOvesco Endoscopy AG K170867FTRD System SetOvesco Endoscopy AG K182556SureClip Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd. K180325Single Use MultiClip DeviceMicro-Tech (Nanjing) Co., Ltd. K172727HemoclipHangzhou AGS MedTech Co., Ltd. K180689Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure deviceSTERIS Corporation

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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