510(k) Report

Devices descending from K081137

211 later devices reach Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K2302161688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)Stryker20238—
+8K221611780 nm L11 LED Light Source with AIMStryker202210—
+8K220889Senhance Surgical SystemAsensus Surgical, Inc.20222—
+9K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC20260—
+9K252675da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+9K252069da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+9K251426da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+9K251817da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20251—
+9K241635da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20241—
+9K2401741688 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+10K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc.20260—