510(k) Report

Devices descending from K032838

3 later devices reach Celon Ent System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252043Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus…Olympus Winter & Ibe GmbH20250—
+1K191732Sutter RaVoR Bipolar ElectrodesSutter Medizintechnik GmbH20190—
+1K160639Electrosurgical Generator ESG-200Olympus Winter & Ibe GmbH20160—