510(k) Report

Devices descending from K013946

340 later devices reach Flex 10 Accessory for the Afx Microwave Ablation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K232857KARL STORZ ICG Imaging SystemKarl Storz SE & CO. KG20230—
+9K222240Explorer Air® IISurgvision GmbH20231—
+9K223039da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20223—
+9K222849AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris20220—
+9K221217SPY LaparoscopeStryker20221—
+9K220477Cellvizio 100 series system with confocal MiniprobesMauna Kea Technologies20221—
+9K2112021688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S…Stryker202119—
+9K202166Senhance Surgical SystemTransenterix, Inc.20215—
+9K201399HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid…Karl Storz-Endoscopy-America, Inc.20208—
+9K201255TSolution® One Total Knee ApplicationTHINK Surgical, Inc.20203—
+9K193135TSolution One Total Knee ApplicationTHINK Surgical, Inc.20194—
+10K253602Precision S 4K SinuscopeStryker Endoscopy20260—
+10K251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.20260—
+10K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG20260—
+10K252675da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+10K252069da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+10K252640VereSee Optical Veres Needle and Endoscopic CameraFreyja Healthcare, LLC20251—
+10K251426da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+10K251817da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20251—
+10K252010SPY LaparoscopeStryker Endoscopy20250—
+10K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+10K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH20240—
+10K231212da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20232—
+10K2221301688 4K Camera System with Advanced Imaging ModalityStryker20220—
+10K214046780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight CableStryker202214—
+10K2208951688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K…Stryker20220—
+10K2125111688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K…Stryker20210—
+10K212054Senhance Surgical SystemAsensus Surgical, Inc.20213—
+10K211325Senhance Surgical SystemAsensus Surgical, Inc.20210—
+10K203040TSolution One Total Knee ApplicationTHINK Surgical, Inc.20202—
+11K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC20260—
+11K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc.20260—
+11K241635da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20241—
+11K230754L12 LED Light Source with AIMStryker20236—
+11K2306051788 4K Camera System with Advanced Imaging ModalityStryker20236—
+11K2302161688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)Stryker20238—
+11K221611780 nm L11 LED Light Source with AIMStryker202210—
+11K220889Senhance Surgical SystemAsensus Surgical, Inc.20222—
+11K210668TSolution One Total Knee ApplicationTHINK Surgical, Inc.20210—
+12K2401741688 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—