510(k) Report

Devices descending from K970882

14 later devices reach Endolight End Irrigating Endo-Illuminator (20 GA. and 19 GA.) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080067Iscience Interventional Ophthalmic MicrocatheterIscience Interventional200892
+1K041108Iscience Surgical Ophthalmic MicrocannulaIscience Surgical Corporation200410—
+1K991323Smith & Nephew Subcutaneous IlluminatorSmith & Nephew, Inc.19992—
+2K253468Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)Nova Eye, Inc.20260—
+2K221872ITrack Advance Canaloplasty Microcatheter with Advanced Delivery SystemNova Eye Inc. (Business Name Nova Eye Medical)20230—
+2K173332OMNI Surgical SystemSight Sciences, Inc.20176—
+2K032387Trivex SystemSmith & Nephew, Inc.200311
+3K243503VIA360™ Surgical SystemNew World Medical, Inc.20250—
+3K212894PhasTIPPLeMaitre Vascular, Inc.20220—
+3K211680Streamline Surgical SystemNew World Medical, Inc.20210—
+3K202678OMNI Surgical SystemSight Sciences, Inc.20212—
+3K201953OMNI PLUS Surgical SystemSight Sciences, Inc.20200—
+4K232214OMNI Surgical SystemSight Sciences, Inc.20231—
+5K253760OMNI Ultra Surgical System (1-110)Sight Sciences, Inc.20260—