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FDA 510(k)

NeoNavia Biopsy System

K-Number: K220595 · 2022-09-08

ApplicantNeodynamics AB
Decision Date2022-09-08
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NeoNavia Biopsy System is a medical device manufactured by Neodynamics AB. It received FDA 510(k) clearance on 2022-09-08 under approval number K220595. 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 NeoNavia Biopsy System?

NeoNavia Biopsy System is a medical device that received FDA 510(k) clearance on 2022-09-08. It is manufactured by Neodynamics AB. The 510(k) number is K220595.

When was NeoNavia Biopsy System approved by the FDA?

NeoNavia Biopsy System received FDA 510(k) clearance on 2022-09-08, under approval number K220595.

What company makes NeoNavia Biopsy System?

NeoNavia Biopsy System is manufactured by Neodynamics AB.

What is the FDA product code for NeoNavia Biopsy System?

The FDA product code for NeoNavia Biopsy System is 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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