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FDA 510(k)

SUREcore Prime Biopsy Instrument

K-Number: K230646 · 2023-11-29

ApplicantUro-1 Medical, Inc.
Decision Date2023-11-29
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SUREcore Prime Biopsy Instrument is a medical device manufactured by Uro-1 Medical, Inc.. It received FDA 510(k) clearance on 2023-11-29 under approval number K230646. 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 SUREcore Prime Biopsy Instrument?

SUREcore Prime Biopsy Instrument is a medical device that received FDA 510(k) clearance on 2023-11-29. It is manufactured by Uro-1 Medical, Inc.. The 510(k) number is K230646.

When was SUREcore Prime Biopsy Instrument approved by the FDA?

SUREcore Prime Biopsy Instrument received FDA 510(k) clearance on 2023-11-29, under approval number K230646.

What company makes SUREcore Prime Biopsy Instrument?

SUREcore Prime Biopsy Instrument is manufactured by Uro-1 Medical, Inc..

What is the FDA product code for SUREcore Prime Biopsy Instrument?

The FDA product code for SUREcore Prime Biopsy Instrument is KNW.

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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