510(k) Report

Devices descending from K013165

117 later devices reach Usa Series Laparoscopes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K214046780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight CableStryker202214—
+6K2208951688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K…Stryker20220—
+6K220477Cellvizio 100 series system with confocal MiniprobesMauna Kea Technologies20221—
+6K2125111688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K…Stryker20210—
+7K251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.20260—
+7K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG20260—
+7K252640VereSee Optical Veres Needle and Endoscopic CameraFreyja Healthcare, LLC20251—
+7K252350da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20250—
+7K252010SPY LaparoscopeStryker Endoscopy20250—
+7K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+7K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH20240—
+7K230754L12 LED Light Source with AIMStryker20236—
+7K2306051788 4K Camera System with Advanced Imaging ModalityStryker20236—
+7K2302161688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)Stryker20238—
+7K221611780 nm L11 LED Light Source with AIMStryker202210—
+8K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC20260—
+8K2401741688 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—