Class Class II

extriCARE® 3000 Negative Wound Pressure Therapy System (K221223)

K221223 2023-02-09 Traditional
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Description

extriCARE® 3000 Negative Wound Pressure Therapy System by Alleva Medical Devices, an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK221223
Clearance Date2023-02-09
Clearance TypeTraditional
Product CodeOMP
Regulation Number878.4780

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Predicate lineage for K221223

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. extriCARE® 3000 Negative Wound Pressure Therapy System (K221223) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K132225EXTRICAREDevon Medical, Inc.2014

Trace the full predicate network for K221223

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.

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