510(k) Report

Devices descending from K210279

3 later devices reach Enbio S through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250164Cassette Autoclave (ACA5)Guangzhou Ajax Medical Equipment Co., Ltd.20250—
+1K213991Enbio SEnbio Group AG20221—
+2K260254Enbio PROEnbio Group AG20260—