Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Uramix CuraWay Biopsy Needle

K-Number: K203141 · 2021-09-17

ApplicantUramix, Inc.
Decision Date2021-09-17
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Uramix CuraWay Biopsy Needle is a medical device manufactured by Uramix, Inc.. It received FDA 510(k) clearance on 2021-09-17 under approval number K203141. 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 Uramix CuraWay Biopsy Needle?

Uramix CuraWay Biopsy Needle is a medical device that received FDA 510(k) clearance on 2021-09-17. It is manufactured by Uramix, Inc.. The 510(k) number is K203141.

When was Uramix CuraWay Biopsy Needle approved by the FDA?

Uramix CuraWay Biopsy Needle received FDA 510(k) clearance on 2021-09-17, under approval number K203141.

What company makes Uramix CuraWay Biopsy Needle?

Uramix CuraWay Biopsy Needle is manufactured by Uramix, Inc..

What is the FDA product code for Uramix CuraWay Biopsy Needle?

The FDA product code for Uramix CuraWay Biopsy Needle is KNW.

Related Clinical Trials

NCT05231278 Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy COMPLETED NCT00102544 Use of Tracking Devices to Locate Abnormalities During Invasive Procedures ENROLLING_BY_INVITATION NCT05078853 Thyroglobulin Point of Care Assay for Rapid Detection of Metastatic Differentiated Thyroid Carcinoma COMPLETED NCT02759744 Fusion Guided Focal Laser Ablation of Prostate Cancer ENROLLING_BY_INVITATION NCT05465161 STING MARK Universal Fiducial Marker System RECRUITING

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.

↑