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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 the device name listed in this FDA 510(k) record. The listed applicant is Borvo Medical, Inc.. It received FDA 510(k) clearance on 2024-08-20 under 510(k) 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. The listed applicant is Borvo Medical, Inc.. The 510(k) number is K241458.

When did Borvo EVAC System (Ergo); Borvo EVAC System (Classic) receive FDA 510(k) clearance?

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

Who is the listed applicant for Borvo EVAC System (Ergo); Borvo EVAC System (Classic)?

The FDA 510(k) record lists Borvo Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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