510(k) Report

Devices descending from K130483

15 later devices reach Boehringer Gastric Sizing Tube through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K234033ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)Boehringer Laboratories, LLC20241—
+1K234145ViSiGi 3D Gastric Sizing TubeBoehringer Laboratories20241—
+1K222880Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)Endolumik, Inc.20231—
+1K212407Gastric Lightguide (GLG)Naser Dib Gabinet Lekarksi Nasmed20220—
+1K220218Siren SGTTools For Surgery, LLC20221—
+1K191885Standard BougieStandard Bariatrics20203—
+1K142548MidsleeveMedical Innovation Development20150—
+1K143088GastriSail Gastric Positioning SystemCovidien20151—
+2K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLC20260—
+2K242901ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT…Tools For Surgery, LLC20250—
+2K240069Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration…Endolumik20240—
+2K210437Standard Bougie, 38 Fr.Standard Bariatrics20212—
+2K160654GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)Covidien, LLC201601
+3K222085Standard Tapered Bougie, 38 Fr.Standard Bariatrics, Inc.20220—
+3K212728Standard Bougie, 38 Fr. and Hand PumpStandard Bariatrics20210—