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FDA 510(k)

Breast Volume Navigator (BVN) Model G-2000

K-Number: K211098 · 2021-05-26

ApplicantMetritrack, Inc.
Decision Date2021-05-26
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Breast Volume Navigator (BVN) Model G-2000 is a medical device manufactured by Metritrack, Inc.. It received FDA 510(k) clearance on 2021-05-26 under approval number K211098. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Breast Volume Navigator (BVN) Model G-2000?

Breast Volume Navigator (BVN) Model G-2000 is a medical device that received FDA 510(k) clearance on 2021-05-26. It is manufactured by Metritrack, Inc.. The 510(k) number is K211098.

When was Breast Volume Navigator (BVN) Model G-2000 approved by the FDA?

Breast Volume Navigator (BVN) Model G-2000 received FDA 510(k) clearance on 2021-05-26, under approval number K211098.

What company makes Breast Volume Navigator (BVN) Model G-2000?

Breast Volume Navigator (BVN) Model G-2000 is manufactured by Metritrack, Inc..

What is the FDA product code for Breast Volume Navigator (BVN) Model G-2000?

The FDA product code for Breast Volume Navigator (BVN) Model G-2000 is IYO.

Related Clinical Trials

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Related PubMed Literature

PMID: 41779786 Stress-dependent growth in breast cancer arises from a mechano-osmotic coupling and cell-sizing checkpoint. Proceedings of the National Academy of Sciences of the United States of America (2026)

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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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