510(k) Report

Devices descending from K810227

12 later devices reach Model #53110 Disposable Anoscope through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070913Self-Light Disposable AnoscopeSapimed S.P.A.2007111
+2K250645SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)Haemoband Surgical, Ltd.20250—
+2K200021Applied Medical AnoscopeApplied Medical Resources20210—
+2K093896Ethicon Endo Surgery Slotted AnoscopeEthicon Endo-Surgery, Inc.20100—
+2K090432Hemorpex SystemAngiologica B. M. Srl20090—
+2K080132THD Disposable Anoscope/ProctoscopeThd Spa20086—
+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—