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FDA 510(k)

SUREcore Plus Biopsy Instrument

K-Number: K220611 · 2022-12-02

ApplicantUro-1, Inc.
Decision Date2022-12-02
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SUREcore Plus Biopsy Instrument is a medical device manufactured by Uro-1, Inc.. It received FDA 510(k) clearance on 2022-12-02 under approval number K220611. 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 Plus Biopsy Instrument?

SUREcore Plus Biopsy Instrument is a medical device that received FDA 510(k) clearance on 2022-12-02. It is manufactured by Uro-1, Inc.. The 510(k) number is K220611.

When was SUREcore Plus Biopsy Instrument approved by the FDA?

SUREcore Plus Biopsy Instrument received FDA 510(k) clearance on 2022-12-02, under approval number K220611.

What company makes SUREcore Plus Biopsy Instrument?

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

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

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

Other Devices by Uro-1, Inc.

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Related Devices (Code: KNW)

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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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