Class Class II
Borvo EVAC System (Ergo); Borvo EVAC System (Classic) (K241458)
Description
Borvo EVAC System (Ergo); Borvo EVAC System (Classic) by Borvo Medical, Inc., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241458
Clearance Date2024-08-20
Clearance TypeTraditional
Product CodeJXG
Regulation Number882.5550
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241458
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Borvo EVAC System (Ergo); Borvo EVAC System (Classic) (K241458) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K042349 | EMG MODEL SUA01 SUCTION UNIT | Emg Technology Co., Ltd. | 2004 |
| K042359 | SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA... | Medical Designs, LLC | 2004 |
Trace the full predicate network for K241458
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.