510(k) Report

Devices descending from K190062

4 later devices reach STATCLAVE G4 Chamber Autoclave through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210279Enbio SEnbio Group AG20213—
+2K250164Cassette Autoclave (ACA5)Guangzhou Ajax Medical Equipment Co., Ltd.20250—
+2K213991Enbio SEnbio Group AG20221—
+3K260254Enbio PROEnbio Group AG20260—