510(k) Report

Devices descending from K031133

56 later devices reach Surgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111202Surgical Tissue Management SystemOlympus Medical Systems Corp.20121110
+1K081129Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD…Surgrx, Inc.200824—
+1K071728Modification to: Enseal PTC Tissue Sealing DeviceSurgrx, Inc.200716—
+1K061526Enseal PTC Tissue Sealing DeviceSurgrx, Inc.200653—
+1K050671Enseal Vessel Sealing & Hemostasis SystemSurgrx, Inc.200526—
+1K043008Surgrx Enseal Vessel Sealing & Hemostasis SystemSurgrx, Inc.200425—
+2K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+2K172691Ultrasonic GeneratorOlympus Medical Systems Corp.20174—
+2K132703ThunderbeatOlympus Medical Systems Corp.20149—
+2K130266Endowrist One Vessel SealerIntuitive Surgical, Inc.2013101
+2K110639Endowrist One Vessel SealerIntuitive Surgical, Inc.2011152
+2K101990Ethicon Endo-Surgery Generator G11, Model GEN11Ethicon Endo-Sugery, LLC201111—
+2K070896Enseal PTC Tissue Sealing DeviceSurgrx, Inc.2007321
+2K070165Enseal PTC TrioSurgrx, Inc.2007251
+2K062949Enseal PTC Tissue Seating Sealing DeviceSurgrx, Inc.200626—
+2K063097Enseal PTC Tissue Sealing DeviceSurgrx, Inc.200634—
+3K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+3K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+3K242894SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic…Shanghai Saints Sages Surgical Co., Ltd.20250—
+3K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+3K180575THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.20180—
+3K172610THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.201843
+3K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+3K123329DA Vinvi Surgical SystemIntuitive Surgical, Inc.20143—
+3K141122Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC20149—
+3K140189Endowrist Vessel SealerIntuitive Surgical, Inc.201491
+3K123141Enseal Trio Tissue Sealing DeviceEthicon Endo-Surgery, LLC20126—
+4K2104788mm Monopolar Curved ScissorsIconocare Health20220—
+4K212614Ultrasonic Scalpel SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20221—
+4K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+4K173415EndoWrist 5mm Thoracic GrasperIntuitive Surgical, Inc.20180—
+4K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc.20170—
+4K170908PK AIMGyrus Acmi, Inc.20170—
+4K170865EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site…Intuitive Surgical, Inc.20178—
+4K160554Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20166—
+4K131435Enseal G2 Tissue Sealer, Straight Jaw, Enseal G2 Tissue Sealer, Curved Jaw, Enseal Trio…Ethicon Endo-Surgery, LLC20135—
+5K233036Ultrasonic Surgical SystemHunan Handlike Minimally Invasive Surgery Co., Ltd.20240—
+5K201696ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer…Ethicon Endo-Surgery, LLC20211—
+5K201066ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved…Ethicon Endo-Surgery, LLC20211—
+5K200841Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11Ethicon Endo-Surgery, LLC20204—
+5K180403ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue…Ethicon Endo-Surgery, LLC20180—
+5K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc.201871
+5K172580ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer…Ethicon Endo-Surgery, LLC201703
+5K163548ENSEAL X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20170—
+6K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC20260—
+6K243067The ETHICON™ Total Energy SystemEthicon Endo-Surgery, LLC (A Johnson and Johnson Company)20250—
+6K241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed…Stryker Sustainability Solutions20240—
+6K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…Stryker Sustainability Solutions20241—
+6K230387ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue…Ethicon Endo-Surgery, LLC20230—
+6K183107Intuitive Surgical Vessel Sealer ExtendIntuitive Surgical, Inc.20186—
+7K250674Vessel Sealer Curved (480522)Intuitive Surgical, Inc.20250—
+7K191280E-100 Electrosurgical Generator, SynchroSealIntuitive Surgical, Inc.201942
+8K223039da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20223—
+9K231212da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20232—
+10K241635da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20241—
+11K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc.20260—