510(k) Report

Devices descending from K770291

12 later devices reach Sigmoidoscope, Disposable, Model #53125 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232262LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye®…Surgease Innovations Limited20230—
+1K123013Endoscopic IntroducerNovadaq Technologies, Inc.20130—
+1K070915Sapimed Disposable SigmoidoscopeSapimed S.P.A.200791
+2K133393Gelpoint Path Transanal Access PlatformApplied Medical Resources Corp.20141—
+2K080132THD Disposable Anoscope/ProctoscopeThd Spa20086—
+3K171701GelPOINT Path Transanal Access PlatformApplied Medical Resources Corp.201701
+3K093497THD BandyThd Spa20100—
+3K091490Family of THD Disposable Anoscopes/Proctoscopes/RectoscopesThd Spa20094—
+4K103647THD Disposable Anoscopes, Proctoscopes and RectoscopesThd Spa20113—
+5K133687THD N-Ano AnoscopeThd Spa20130—
+5K121135THD Anoscope, Proctoscope, Rectoscope, Rectoscope and Light-ScopeThd Spa20121—
+6K230439WellCare AnoscopeWell Care (Wuhan) Medical Technology Co., Ltd.20230—