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FDA 510(k)

Promisemed Fine Biopsy Needle

K-Number: K213683 · 2022-04-22

ApplicantPromisemed Hangzhou Meditech Co., Ltd.
Decision Date2022-04-22
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Promisemed Fine Biopsy Needle is a medical device manufactured by Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2022-04-22 under approval number K213683. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Promisemed Fine Biopsy Needle?

Promisemed Fine Biopsy Needle is a medical device that received FDA 510(k) clearance on 2022-04-22. It is manufactured by Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K213683.

When was Promisemed Fine Biopsy Needle approved by the FDA?

Promisemed Fine Biopsy Needle received FDA 510(k) clearance on 2022-04-22, under approval number K213683.

What company makes Promisemed Fine Biopsy Needle?

Promisemed Fine Biopsy Needle is manufactured by Promisemed Hangzhou Meditech Co., Ltd..

What is the FDA product code for Promisemed Fine Biopsy Needle?

The FDA product code for Promisemed Fine Biopsy Needle is KNW.

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Other Devices by Promisemed Hangzhou Meditech Co., Ltd.

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Related Devices (Code: KNW)

K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer NeedlesM.D.L. S.R.L. K153709Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer StyletDevicor Medical Products, Inc. K161234CASSI II Rotational Core Biopsy SystemScion Medical Technologies, LLC K161409M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for SemMermaid Medical A/S K161805EnCor MRI Introducer Set, EnCor Probe IntroducerSenorx, Inc. K153337Corvocet Biopsy SystemMerit Medical Systems, Inc.

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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