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510(k) K241458

Borvo EVAC System (Ergo); Borvo EVAC System (Classic) by Borvo Medical, Inc. — Product Code JXG

K241458 is an FDA 510(k) premarket notification submitted by Borvo Medical, Inc. for the device "Borvo EVAC System (Ergo); Borvo EVAC System (Classic)". The FDA issued a decision of Substantially Equivalent on August 20, 2024. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2024
Date Received
May 23, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type

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FDA data resources