510(k) Report

Devices descending from K032676

172 later devices reach Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K121309Asc Quadport + Laparoscopic Access DeviceAdvanced Surgical Concepts20120—
+4K120898Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport Trucar 8850XX…Richard Wolf Medical Instruments Corp.20120—
+4K111407Triport, Triport+, TRIPORT15, QuadportAdvanced Surgical Concepts20120—
+4K103253Sils PortCoviden (Formerly Registered AS US Surgical, A Div20114—
+5K261706Endomat Select (UP220)Karl Storz SE & CO. KG20260—
+5K242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.20250—
+5K241360Universal Seal (5-12 mm)Intuitive Surgical, Inc.20242—
+5K213171Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable…Meditrina, Inc.20221—
+5K201361PneumoclearW.O.M. World of Medicine GmbH202014—
+5K193520EVA 15 InsufflatorPalliare, Ltd.20205—
+5K192100Aveta Disposable HysteroscopeMeditrina, Inc.20190—
+5K191958Aveta SystemMeditrina, Inc.20190—
+5K190303AirSealConmed Corporation20191—
+5K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2019204
+5K170865EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site…Intuitive Surgical, Inc.20178—
+5K150705FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic…Minimally Invasive Devices, Inc.20153—
+5K110792Gelpoint PathApplied Medical Resources Corp.20113—
+6K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KG20260—
+6K253978Universal Seal (5-12 mm)Intuitive Surgical, Inc.20261—
+6K250388Endoflator +Karl Storz SE & CO. KG20251—
+6K241796TroCare TroKit Laparoscope Lens Wiper (CP000626)TroCare, LLC20242—
+6K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc.2024116
+6K223813Aveta System 2.0Meditrina, Inc.20230—
+6K230474EVA5 InsufflatorPalliare, Ltd.20231—
+6K211104AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube SetConmed Corporation20210—
+6K202571da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2020141
+6K202799EVA15Palliare, Ltd.20204—
+6K192717da Vinci SP Surgical SystemIntuitive Surgical, Inc.202041
+6K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc.201871
+6K171701GelPOINT Path Transanal Access PlatformApplied Medical Resources Corp.201701
+6K133393Gelpoint Path Transanal Access PlatformApplied Medical Resources Corp.20141—
+7K262152VS-370CF, VS-370CTVISION MEDICAL Co., Ltd.20260—
+7K261249Universal Seal (5-12 mm)Intuitive Surgical, Inc.20260—
+7K253994TroKit Laparoscope Lens WiperTroCare, LLC20260—
+7K260089TL-10 Laparoscopic Scope CleanerScopix, Ltd.20260—
+7K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20262—
+7K251227da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+7K250442da Vinci Surgical System, IS5000Intuitive Surgical, Inc.20250—
+7K251213Da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+7K251202da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20251—
+7K243582da Vinci SP Advanced Access Port Kit (432701)Intuitive Surgical, Inc.20250—
+7K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20241—
+7K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20242—
+7K230033Da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202312—
+7K222901EVA15 insufflatorPalliare, Ltd.20233—
+7K202968Da Vinci SP Surgical SystemIntuitive Surgical, Inc.202031
+7K183107Intuitive Surgical Vessel Sealer ExtendIntuitive Surgical, Inc.20186—
+8K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+8K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+8K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+8K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.20260—
+8K250674Vessel Sealer Curved (480522)Intuitive Surgical, Inc.20250—
+8K232902EVA15 insufflatorPalliare, Ltd.20240—
+8K231798da Vinci SP Surgical SystemIntuitive Surgical, Inc.202311—
+8K211316da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202111
+8K211595da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202101
+8K191280E-100 Electrosurgical Generator, SynchroSealIntuitive Surgical, Inc.201942
+9K240502da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20249—
+9K232773da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20240—
+9K223039da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20223—
+9K212747Da Vinci SP Surgical SystemIntuitive Surgical, Inc.20210—
+10K242318da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20247—
+10K241814da Vinci SP Instruments (SP1098)Intuitive Surgical, Inc.20240—
+10K231212da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20232—
+11K251324da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+11K243714da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20255—
+11K241635da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20241—
+12K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc.20260—
+12K252675da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+12K252069da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+12K251426da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+12K251817da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20251—