510(k) Report

Devices descending from K012265

107 later devices reach Metal Halide Light Source, Models MV-9088-T, MV-9088 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—