510(k) Report

Devices descending from K070915

9 later devices reach Sapimed Disposable Sigmoidoscope through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133393Gelpoint Path Transanal Access PlatformApplied Medical Resources Corp.20141—
+1K080132THD Disposable Anoscope/ProctoscopeThd Spa20086—
+2K171701GelPOINT Path Transanal Access PlatformApplied Medical Resources Corp.201701
+2K093497THD BandyThd Spa20100—
+2K091490Family of THD Disposable Anoscopes/Proctoscopes/RectoscopesThd Spa20094—
+3K103647THD Disposable Anoscopes, Proctoscopes and RectoscopesThd Spa20113—
+4K133687THD N-Ano AnoscopeThd Spa20130—
+4K121135THD Anoscope, Proctoscope, Rectoscope, Rectoscope and Light-ScopeThd Spa20121—
+5K230439WellCare AnoscopeWell Care (Wuhan) Medical Technology Co., Ltd.20230—