510(k) Report

Devices descending from K031011

114 later devices reach Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K222284Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)Applied Medical Resources Corporation20220—
+5K212614Ultrasonic Scalpel SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20221—
+5K212643POWERSEAL Curved Jaw Sealer and Divider, Double ActionOlympus Surgical Technologies America202117
+5K203183CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)Bolder Surgical, LLC20212—
+5K182451BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/DividerCovidien, LLC20181—
+5K160554Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20166—
+6K233036Ultrasonic Surgical SystemHunan Handlike Minimally Invasive Surgery Co., Ltd.20240—
+6K200841Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11Ethicon Endo-Surgery, LLC20204—
+6K193356BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/DividerCovidien, LLC20200—
+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—