FDA 510(k)

EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G

K-Number: K192948 · 2019-11-07

Decision Date2019-11-07

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G is a medical device manufactured by Bard Peripheral Vascular, Inc.. It received FDA 510(k) clearance on 2019-11-07 under approval number K192948. 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 EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G?

EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G is a medical device that received FDA 510(k) clearance on 2019-11-07. It is manufactured by Bard Peripheral Vascular, Inc.. The 510(k) number is K192948.

When was EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G approved by the FDA?

EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G received FDA 510(k) clearance on 2019-11-07, under approval number K192948.

What company makes EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G?

EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G is manufactured by Bard Peripheral Vascular, Inc..

What is the FDA product code for EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G?

The FDA product code for EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G is KNW.

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Related Devices (Code: KNW)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.