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FDA 510(k)

Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles

K-Number: K210946 · 2021-08-12

ApplicantPromisemed Hangzhou Meditech Co., Ltd.
Decision Date2021-08-12
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles is a medical device manufactured by Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2021-08-12 under approval number K210946. 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 Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles?

Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles is a medical device that received FDA 510(k) clearance on 2021-08-12. It is manufactured by Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K210946.

When was Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles approved by the FDA?

Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles received FDA 510(k) clearance on 2021-08-12, under approval number K210946.

What company makes Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles?

Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles is manufactured by Promisemed Hangzhou Meditech Co., Ltd..

What is the FDA product code for Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles?

The FDA product code for Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles is KNW.

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Other Devices by Promisemed Hangzhou Meditech Co., Ltd.

K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle K193009Promisemed Heel Blood Lancet K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet K191853Dual-Safety Pen Needle K202681Promisemed Covered Safety Pen Needle K202682Promisemed Triple Safety Pen Needle

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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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