510(k) Report

Devices descending from K944602

319 later devices reach Valleylab Force FX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K233849BTL-499BTL Industries, Inc.20240—
+7K233604BTL-785SBTL Industries, Inc.20243—
+7K230272Renuvion® APR HandpieceApyx Medical Corporation20231—
+7K230387ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue…Ethicon Endo-Surgery, LLC20230—
+7K230255Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019Stryker Sustainability Solutions20230—
+7K223262Renuvion® APR HandpieceApyx Medical Corporation20232—
+7K191601Valleylab FT10 Electrosurgical PlatformCovidien201911
+7K182451BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/DividerCovidien, LLC20181—
+7K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc.201871
+8K260397SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)Hironic Co., Ltd.20260—
+8K253750BTL-785NEHBTL Industries, Inc.20260—
+8K242532BTL-785BNF-EBTL Industries, Inc.20241—
+8K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)Covidien, LLC20240—
+8K230586Renuvion® Micro HandpieceApyx Medical Corporation20230—
+8K193356BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/DividerCovidien, LLC20200—
+8K183107Intuitive Surgical Vessel Sealer ExtendIntuitive Surgical, Inc.20186—
+9K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+9K250674Vessel Sealer Curved (480522)Intuitive Surgical, Inc.20250—
+9K191280E-100 Electrosurgical Generator, SynchroSealIntuitive Surgical, Inc.201942