510(k) Report

Devices descending from K201361

14 later devices reach Pneumoclear through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KG20260—
+1K250388Endoflator +Karl Storz SE & CO. KG20251—
+1K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc.2024116
+2K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20262—
+2K251227da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+2K250442da Vinci Surgical System, IS5000Intuitive Surgical, Inc.20250—
+2K251213Da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+2K251202da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20251—
+2K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20241—
+2K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20242—
+3K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+3K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+3K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+3K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.20260—