510(k) Report

Devices descending from K993054

263 later devices reach Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5, LCS-C1… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K243582da Vinci SP Advanced Access Port Kit (432701)Intuitive Surgical, Inc.20250—
+5K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20241—
+5K241872Remanufactured EndoWrist ProGrasp Forceps (420093)Rebotix20240—
+5K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20242—
+5K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+5K230033Da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202312—
+5K210918da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20216—
+5K202968Da Vinci SP Surgical SystemIntuitive Surgical, Inc.202031
+5K191529da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical202012—
+5K190081RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber…STERIS Corporation20194—
+5K191736da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30Intuitive Surgical20190—
+5K180575THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.20180—
+5K173906da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2018219
+5K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc.201871
+5K172610THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.201843
+5K171120Senhance Surgical Robotic SystemTransenterix, Inc.201712—
+5K150956PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.2016701
+5K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+5K150705FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic…Minimally Invasive Devices, Inc.20153—
+5K123840Connect for DA Vinci Surgical System (S)Intuitive Surgical, Inc.20130—
+5K121921Intuitive Surgical Onsite for DA Vinci Surgical SystemsIntuitive Surgical, Inc.20120—
+5K113706Endowrist Stapler SystemIntuitive Surgical, Inc.201221
+5K112208Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc.20114312
+5K101581Intuitive Surgical DA Vinci S Surgical System with DA Vinci Connect & DA Vinci Onsite…Intuitive Surgical, Inc.20116—
+5K101077DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc.20111042
+5K080291Intuitive Surgical DA Vinci Endoscopic Instruments and Control System and Endowrist…Intuitive Surgical, Inc.200801
+6K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+6K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+6K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+6K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.20260—
+6K241796TroCare TroKit Laparoscope Lens Wiper (CP000626)TroCare, LLC20242—
+6K231798da Vinci SP Surgical SystemIntuitive Surgical, Inc.202311—
+6K213710da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20222—
+6K212101da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20212—
+6K211316da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202111
+6K202582Arthrex SynergyID Endoscopic Imaging SystemArthrex, Inc.20215—
+6K211595da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202101
+6K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+6K200577RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber…STERIS Corporation20203—
+6K192292L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight CableStryker20191—
+6K183107Intuitive Surgical Vessel Sealer ExtendIntuitive Surgical, Inc.20186—
+6K182606PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker)201844—
+6K1821601688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head…Stryker2018331
+6K181517Senhance Surgical SystemTransenterix, Inc.201810—
+6K180163TransEnterix Senhance Surgical SystemTransenterix, Inc.201811—
+6K170879IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30…Intuitive Surgical, Inc.20170—
+6K171388EndoWrist Stapler 45 System and Stapler 45 ReloadsIntuitive Surgical, Inc.20171—
+6K170908PK AIMGyrus Acmi, Inc.20170—
+6K161792PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.201668—
+6K124031DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc.2013103—
+6K130726DA Vinci Single-Site Permanent Cautery HookIntuitive Surgical, Inc.201327
+6K120215Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper, Single-Site Fundus…Intuitive Surgical, Inc.2012423
+7K253994TroKit Laparoscope Lens WiperTroCare, LLC20260—
+7K2603184K NIR/ICG Imaging SystemZhejiang Healnoc Technology Co., Ltd.20260—
+7K260089TL-10 Laparoscopic Scope CleanerScopix, Ltd.20260—
+7K250674Vessel Sealer Curved (480522)Intuitive Surgical, Inc.20250—
+7K250786SP Endoscope, 0° (430600)Intuitive Surgical, Inc.20251—
+7K243591OPTOVISION Endoscopic Light Source UnitOptosurgical, LLC20250—
+7K240502da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20249—
+7K233840Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)Zhuhai Dipu Medical Technology Co., Ltd.20240—
+7K2338923D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)Zhuhai Dipu Medical Technology Co., Ltd.20240—
+7K232773da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20240—
+7K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker20235—
+7K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+7K221591Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)…Schoelly Fiberoptic GmbH20231—
+7K221861FloNavi Endoscopic Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20232—
+7K221252Scivita 4KINSIGHT ICG Imaging SystemScivita Medical Technology Co., Ltd.20230—
+7K213943SmartSurgN Visualization SystemSmartsurgn Incorporated20221—
+7K222827da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20220—
+7K212808Logic Hd camera head green, System greenRichard Wolf Medical Instruments Corporation20220—
+7K212747Da Vinci SP Surgical SystemIntuitive Surgical, Inc.20210—
+7K202925KARL STORZ ICG Imaging SystemKarl Storz Endoscopy_America, Inc.20207—
+7K203199RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single…STERIS Corporation20202—
+7K202592Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality…Stryker202026—
+7K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)20208—
+7K2003101688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with…Stryker20200—
+7K191851VS3-IRMedtronic20196—
+7K191280E-100 Electrosurgical Generator, SynchroSealIntuitive Surgical, Inc.201942
+7K191482Senhance Surgical SystemTransenterix, Inc.20198—
+7K191046L10 LED Light Source with AIM, L11 LED Light Source with AIMStryker20192—
+7K183098Senhance Surgical SystemTransenterix, Inc.20180—
+7K152583KARL STORZ Endoscopic ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201636—
+7K142310Stryker Infrared Fluorescence (IRF) Imaging SystemStryker Endoscopy201476—
+7K133203Single-Site PortIntuitive Surgical, Inc.20140—
+8K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+8K242163SmartSurgN Visualization SystemSmartsurgN, Inc.20260—
+8K260108L12 LED Light Source with AIMStryker Endoscopy20260—
+8K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…Olympus Medical Systems Corp.20250—
+8K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—
+8K252350da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20250—
+8K242318da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20247—
+8K241814da Vinci SP Instruments (SP1098)Intuitive Surgical, Inc.20240—
+8K241530Stellar Imaging SystemGuangdong Optomedic Technologies, Inc.20241—
+8K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+8K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+8K2333271788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+8K230407FloNavi Open Field Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20230—
+8K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker)20234—
+8K223039da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20223—
+8K223020VS3-Iridium System (VS3-IR)Visionsense, Ltd.20220—