510(k) Report

Devices descending from K002838

24 later devices reach Gastric Suction and Drainage Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220455Lap-Band System Calibration TubeReshape Lifesciences20224—
+1K110529Endoflip Gastric TubeCrospon, Ltd.201116—
+1K030841Cook Gastric Sizing Balloon CatheterCook, Inc.20031—
+2K241039ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017)…Reshape Lifesciences20240—
+2K221898Gastrointestinal Boundary Identifier (GIBI HD)Reshape Lifesciences20222—
+2K173355Gastric Sizing Balloon CatheterCook Incorporated20170—
+2K130483Boehringer Gastric Sizing TubeBoehringer Laboratories, LLC201315—
+3K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd20250—
+3K234033ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)Boehringer Laboratories, LLC20241—
+3K234145ViSiGi 3D Gastric Sizing TubeBoehringer Laboratories20241—
+3K222880Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)Endolumik, Inc.20231—
+3K230131ReShape Calibration TubesReshape Lifesciences20230—
+3K212407Gastric Lightguide (GLG)Naser Dib Gabinet Lekarksi Nasmed20220—
+3K220218Siren SGTTools For Surgery, LLC20221—
+3K191885Standard BougieStandard Bariatrics20203—
+3K142548MidsleeveMedical Innovation Development20150—
+3K143088GastriSail Gastric Positioning SystemCovidien20151—
+4K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLC20260—
+4K242901ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT…Tools For Surgery, LLC20250—
+4K240069Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration…Endolumik20240—
+4K210437Standard Bougie, 38 Fr.Standard Bariatrics20212—
+4K160654GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)Covidien, LLC201601
+5K222085Standard Tapered Bougie, 38 Fr.Standard Bariatrics, Inc.20220—
+5K212728Standard Bougie, 38 Fr. and Hand PumpStandard Bariatrics20210—