510(k) Report

Devices descending from K012833

233 later devices reach Intuitive Surgical Bipolar Forceps through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K2112021688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S…Stryker202119—
+8K200049Senhance Surgical SystemTransenterix, Inc.20206—
+8K180146KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc.201830—
+8K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201731—
+9K253602Precision S 4K SinuscopeStryker Endoscopy20260—
+9K251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.20260—
+9K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG20260—
+9K252675da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+9K252069da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+9K252640VereSee Optical Veres Needle and Endoscopic CameraFreyja Healthcare, LLC20251—
+9K251426da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+9K251817da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20251—
+9K252010SPY LaparoscopeStryker Endoscopy20250—
+9K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+9K233391cCeLL - In vivoVPIX Medical, Inc.20240—
+9K241635da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20241—
+9K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH20240—
+9K2221301688 4K Camera System with Advanced Imaging ModalityStryker20220—
+9K214046780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight CableStryker202214—
+9K2208951688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K…Stryker20220—
+9K2125111688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K…Stryker20210—
+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—
+10K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC20260—
+10K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc.20260—
+10K230754L12 LED Light Source with AIMStryker20236—
+10K2306051788 4K Camera System with Advanced Imaging ModalityStryker20236—
+10K2302161688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)Stryker20238—
+10K221611780 nm L11 LED Light Source with AIMStryker202210—
+10K212054Senhance Surgical SystemAsensus Surgical, Inc.20213—
+10K211325Senhance Surgical SystemAsensus Surgical, Inc.20210—
+11K2401741688 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+11K220889Senhance Surgical SystemAsensus Surgical, Inc.20222—