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FDA 510(k)

Single Use MultiClip Device

K-Number: K180325 · 2018-06-01

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2018-06-01
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single Use MultiClip Device is a medical device manufactured by Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2018-06-01 under approval number K180325. 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 MultiClip Device?

Single Use MultiClip Device is a medical device that received FDA 510(k) clearance on 2018-06-01. It is manufactured by Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K180325.

When was Single Use MultiClip Device approved by the FDA?

Single Use MultiClip Device received FDA 510(k) clearance on 2018-06-01, under approval number K180325.

What company makes Single Use MultiClip Device?

Single Use MultiClip Device is manufactured by Micro-Tech (Nanjing) Co., Ltd..

What is the FDA product code for Single Use MultiClip Device?

The FDA product code for Single Use MultiClip Device is PKL.

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Related PubMed Literature

PMID: 35349537 Prospective Pilot Study of Robotic-Assisted Harvest of the Latissimus Dorsi Muscle: A 510(k) Approval Study with U.S. Food and Drug Administration Investigational Device Exemption. Plastic and reconstructive surgery (2022) PMID: 35047938 Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Frontiers in medical technology (2021) PMID: 30272398 Obstetrical and Gynecological Devices; Reclassification of Single-Use Female Condom, To Be Renamed Single-Use Internal Condom. Final order. Federal register (2018) PMID: 28291189 Orthopaedic Device Approval Through the Premarket Approval Process: A Financial Feasibility Analysis for a Single Center. The Journal of bone and joint surgery. American volume (2017)

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 K161463SureClip(TM) Repositionable Hemostasis Clip

View all 37 devices →

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. 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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