510(k) Report

Devices descending from K070896

32 later devices reach Enseal PTC Tissue Sealing Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123141Enseal Trio Tissue Sealing DeviceEthicon Endo-Surgery, LLC20126—
+1K081129Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD…Surgrx, Inc.200824—
+2K131435Enseal G2 Tissue Sealer, Straight Jaw, Enseal G2 Tissue Sealer, Curved Jaw, Enseal Trio…Ethicon Endo-Surgery, LLC20135—
+2K111202Surgical Tissue Management SystemOlympus Medical Systems Corp.20121110
+2K101990Ethicon Endo-Surgery Generator G11, Model GEN11Ethicon Endo-Sugery, LLC201111—
+3K242894SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic…Shanghai Saints Sages Surgical Co., Ltd.20250—
+3K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+3K201696ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer…Ethicon Endo-Surgery, LLC20211—
+3K201066ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved…Ethicon Endo-Surgery, LLC20211—
+3K180403ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue…Ethicon Endo-Surgery, LLC20180—
+3K172580ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer…Ethicon Endo-Surgery, LLC201703
+3K172691Ultrasonic GeneratorOlympus Medical Systems Corp.20174—
+3K141122Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC20149—
+3K132703ThunderbeatOlympus Medical Systems Corp.20149—
+4K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+4K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+4K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+4K230387ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue…Ethicon Endo-Surgery, LLC20230—
+4K212614Ultrasonic Scalpel SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20221—
+4K180575THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.20180—
+4K172610THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.201843
+4K160554Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20166—
+4K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+5K233036Ultrasonic Surgical SystemHunan Handlike Minimally Invasive Surgery Co., Ltd.20240—
+5K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+5K200841Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11Ethicon Endo-Surgery, LLC20204—
+5K170908PK AIMGyrus Acmi, Inc.20170—
+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—