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FDA 510(k)

EleVation Breast Biopsy System

K-Number: K211933 · 2021-07-15

ApplicantBard Peripheral Vascular
Decision Date2021-07-15
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EleVation Breast Biopsy System is a medical device manufactured by Bard Peripheral Vascular. It received FDA 510(k) clearance on 2021-07-15 under approval number K211933. 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 System?

EleVation Breast Biopsy System is a medical device that received FDA 510(k) clearance on 2021-07-15. It is manufactured by Bard Peripheral Vascular. The 510(k) number is K211933.

When was EleVation Breast Biopsy System approved by the FDA?

EleVation Breast Biopsy System received FDA 510(k) clearance on 2021-07-15, under approval number K211933.

What company makes EleVation Breast Biopsy System?

EleVation Breast Biopsy System is manufactured by Bard Peripheral Vascular.

What is the FDA product code for EleVation Breast Biopsy System?

The FDA product code for EleVation Breast Biopsy System is KNW.

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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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