510(k) Report

Devices descending from K881004

3 later devices reach Olympus-Keymed Endoscopic CO2 Regulator, Model Ecr through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063786Endoscopic Insufflation Unit, Model Xecr-2Olympus Medical Systems Corporation20072—
+2K133976Fujifilm Endoscopic CO2 RegulatorFujifilm Medical System U.S.A., Inc.20141—
+3K180711FUJIFILM Endoscopic CO2 Regulator GW-100Fujifilm Corporation20180—