510(k) Report

Devices descending from K132612

16 later devices reach Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic Ace +… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242894SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic…Shanghai Saints Sages Surgical Co., Ltd.20250—
+1K221790HARMONIC 700 ShearsEthicon Endo-Surgery, LLC20231—
+1K212614Ultrasonic Scalpel SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20221—
+1K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+1K202554Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced HemostasisStryker Sustainability Solutions20211—
+1K193563Medline ReNewal Reprocessed Harmonic ACE+7 ShearsSurgical Instrument Service and Savings Inc.(Dba Medline Ren202002
+1K161693Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced HemostasisStryker Sustainability Solutions201702
+1K160752HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm LengthEthicon Endo-Suregery, LLC20166—
+2K250898Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears…Stryker Sustainability Solutions20250—
+2K233036Ultrasonic Surgical SystemHunan Handlike Minimally Invasive Surgery Co., Ltd.20240—
+2K191555HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm lengthEthicon Endo-Surgery, LLC202052
+3K200841Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11Ethicon Endo-Surgery, LLC20204—
+4K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC20260—
+4K243067The ETHICON™ Total Energy SystemEthicon Endo-Surgery, LLC (A Johnson and Johnson Company)20250—
+4K241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed…Stryker Sustainability Solutions20240—
+4K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…Stryker Sustainability Solutions20241—