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FER — Anoscope And Accessories Class II

FDA Device Classification

Classification Details

Product Code
FER
Device Class
Class II
Regulation Number
876.1500
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

To examine and perform procedures within the anus and rectum.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250645haemoband surgicalSleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2October 9, 2025
K242668gastro conceptsGastro Concepts Air AssistDecember 13, 2024
K230439well care (wuhan) medical technology coWellCare AnoscopeDecember 22, 2023
K200021applied medical resourcesApplied Medical AnoscopeJanuary 6, 2021
K171701applied medical resourcesGelPOINT Path Transanal Access PlatformJuly 20, 2017
K133393applied medical resourcesGELPOINT PATH TRANSANAL ACCESS PLATFORMJanuary 2, 2014
K133687thdTHD N-ANO ANOSCOPEDecember 11, 2013
K121604obp corporationANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHTJuly 27, 2012
K121135thdTHD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPEJune 1, 2012
K110792applied medical resourcesGELPOINT PATHMay 23, 2011
K103647thdTHD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPESMarch 1, 2011
K093896ethicon endo-surgeryETHICON ENDO SURGERY SLOTTED ANOSCOPEMarch 25, 2010
K091490thdFAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPESJune 11, 2009
K090432angiologica b. mHEMORPEX SYSTEMMay 29, 2009
K080132thdTHD DISPOSABLE ANOSCOPE/PROCTOSCOPEApril 9, 2008
K070913sapimedSELF-LIGHT DISPOSABLE ANOSCOPEAugust 10, 2007
K060623cook irelandSHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPESeptember 6, 2006
K020702canadian theatre productsO'REGAN DISPOSABLE ANOSCOPEMarch 29, 2002
K011825sightline technologiesRECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICEJuly 11, 2001
K994130sightline technologiesRECTOSIGHT RS 300-04June 30, 2000