510(k) Report

Devices descending from K093217

16 later devices reach 5 MM Harmonic Ace Instrument (Used with DA Vinci IS1200 & IS2000/IS3000 System) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123329DA Vinvi Surgical SystemIntuitive Surgical, Inc.20143—
+1K1125845MM/8MM Harmonic Ace (TM) Curved Shears, Disposable Harmonic Ace (TM) Insert, Disposable…Intuitive Surgical, Inc.2011151
+2K2104788mm Monopolar Curved ScissorsIconocare Health20220—
+2K182421Senhance Ultrasonic SystemTransenterix, Inc.20190—
+2K173415EndoWrist 5mm Thoracic GrasperIntuitive Surgical, Inc.20180—
+2K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc.20170—
+2K143132IS4000 8mm Harmonic ACE Curved ShearsIntuitive Surgical, Inc.20159—
+3K170865EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site…Intuitive Surgical, Inc.20178—
+4K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc.201871
+5K183107Intuitive Surgical Vessel Sealer ExtendIntuitive Surgical, Inc.20186—
+6K250674Vessel Sealer Curved (480522)Intuitive Surgical, Inc.20250—
+6K191280E-100 Electrosurgical Generator, SynchroSealIntuitive Surgical, Inc.201942
+7K223039da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20223—
+8K231212da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20232—
+9K241635da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20241—
+10K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc.20260—