510(k) Report

Devices descending from K964175

39 later devices reach Valleylab E2750 Laparoscopic Handset, Valleylab E2770 Series Electrodes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231298Ultravision2™ System Integrated Monopolar L-Hook (H/S)™Alesi Surgical, Ltd.20231—
+1K100711Suction Irrigation Electrodes and AdaptersEncision, Inc.201015
+1K082955Ethicon Endo-Surgery Articulating Hook Knife, Model IN4505Ethicon Endo-Surgery, Inc.20092—
+1K063195Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models LF5034…Valleylab200631—
+2K240868Ultravision2™ IonPencilAlesi Surgical Limited20240—
+2K161804LigaSure Retractable L-Hook Laparoscopic Sealer/DividerCovidien20160—
+2K152219PK AIMGyrus Acmi, Inc.20153—
+2K150835LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol GripCovidien20151—
+2K131949Aem Disposable Suction Irrigation ElectrodesEncision, Inc.20130—
+2K091824Ethicon Endo-Surgery Rotating Endoscopic Scissors, Model IN2507Ethicon Endo-Surgery, Inc.20090—
+2K091290Ethicon Endo-Surgery Rotating Hook Knife, Model IN2508Ethicon Endo-Surgery, Inc.20090—
+2K071759LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand…Live Tissue Connect, Inc.20080—
+2K081129Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD…Surgrx, Inc.200824—
+3K161825PK AIMGyrus Acmi, Inc.20162—
+3K111202Surgical Tissue Management SystemOlympus Medical Systems Corp.20121110
+3K101990Ethicon Endo-Surgery Generator G11, Model GEN11Ethicon Endo-Sugery, LLC201111—
+4K242894SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic…Shanghai Saints Sages Surgical Co., Ltd.20250—
+4K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+4K172691Ultrasonic GeneratorOlympus Medical Systems Corp.20174—
+4K163373PK AIMGyrus Acmi, Inc.20161—
+4K141122Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC20149—
+4K132703ThunderbeatOlympus Medical Systems Corp.20149—
+5K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+5K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+5K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+5K212614Ultrasonic Scalpel SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20221—
+5K180575THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.20180—
+5K172610THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.201843
+5K170908PK AIMGyrus Acmi, Inc.20170—
+5K160554Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20166—
+5K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+6K233036Ultrasonic Surgical SystemHunan Handlike Minimally Invasive Surgery Co., Ltd.20240—
+6K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+6K200841Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11Ethicon Endo-Surgery, LLC20204—
+6K163548ENSEAL X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20170—
+7K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC20260—
+7K243067The ETHICON™ Total Energy SystemEthicon Endo-Surgery, LLC (A Johnson and Johnson Company)20250—
+7K241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed…Stryker Sustainability Solutions20240—
+7K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…Stryker Sustainability Solutions20241—