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FDA 510(k)

Borvo EVAC System (Ergo); Borvo EVAC System (Classic)

K-Number: K241458 · 2024-08-20

ApplicantBorvo Medical, Inc.
Decision Date2024-08-20
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Borvo EVAC System (Ergo); Borvo EVAC System (Classic) is a medical device manufactured by Borvo Medical, Inc.. It received FDA 510(k) clearance on 2024-08-20 under approval number K241458. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Borvo EVAC System (Ergo); Borvo EVAC System (Classic)?

Borvo EVAC System (Ergo); Borvo EVAC System (Classic) is a medical device that received FDA 510(k) clearance on 2024-08-20. It is manufactured by Borvo Medical, Inc.. The 510(k) number is K241458.

When was Borvo EVAC System (Ergo); Borvo EVAC System (Classic) approved by the FDA?

Borvo EVAC System (Ergo); Borvo EVAC System (Classic) received FDA 510(k) clearance on 2024-08-20, under approval number K241458.

What company makes Borvo EVAC System (Ergo); Borvo EVAC System (Classic)?

Borvo EVAC System (Ergo); Borvo EVAC System (Classic) is manufactured by Borvo Medical, Inc..

What is the FDA product code for Borvo EVAC System (Ergo); Borvo EVAC System (Classic)?

The FDA product code for Borvo EVAC System (Ergo); Borvo EVAC System (Classic) is JXG.

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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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