FER · Class II · 21 CFR 876.1500

FDA Product Code FER: Anoscope And Accessories

To Examine And Perform Procedures Within The Anus And Rectum.

Leading manufacturers include Thd Spa, Applied Medical Resources Corp. and Welch Allyn, Inc..

27
Total
27
Cleared
118d
Avg days
1977
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 159d recently vs 114d historically

FDA 510(k) Cleared Anoscope And Accessories Devices (Product Code FER)

27 devices
1–24 of 27
Cleared Oct 09, 2025
SleeveLUX 24 Anoscope/Proctoscope (P2001)
K250645
Haemoband Surgical, Ltd.
Gastroenterology & Urology · 219d
Cleared Dec 13, 2024
Gastro Concepts Air Assist
K242668
Gastro Concepts, LLC
Gastroenterology & Urology · 99d
Cleared Dec 22, 2023
WellCare Anoscope
K230439
Well Care (Wuhan) Medical Technology Co., Ltd.
Gastroenterology & Urology · 304d
Cleared Jan 06, 2021
Applied Medical Anoscope
K200021
Applied Medical Resources
Gastroenterology & Urology · 366d
Cleared Jul 20, 2017
GelPOINT Path Transanal Access Platform
K171701
Applied Medical Resources Corp.
Gastroenterology & Urology · 42d
Cleared Jan 02, 2014
GELPOINT PATH TRANSANAL ACCESS PLATFORM
K133393
Applied Medical Resources Corp.
Gastroenterology & Urology · 58d
Cleared Dec 11, 2013
THD N-ANO ANOSCOPE
K133687
Thd Spa
Gastroenterology & Urology · 9d
Cleared Jul 27, 2012
ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT
K121604
Obp Corporation
Gastroenterology & Urology · 56d
Cleared Jun 01, 2012
THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE
K121135
Thd Spa
Gastroenterology & Urology · 49d
Cleared May 23, 2011
GELPOINT PATH
K110792
Applied Medical Resources Corp.
Gastroenterology & Urology · 63d
Cleared Mar 01, 2011
THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES
K103647
Thd Spa
Gastroenterology & Urology · 78d
Cleared Mar 25, 2010
ETHICON ENDO SURGERY SLOTTED ANOSCOPE
K093896
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 97d
Cleared Jun 11, 2009
FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES
K091490
Thd Spa
Gastroenterology & Urology · 22d
Cleared May 29, 2009
HEMORPEX SYSTEM
K090432
Angiologica B. M. Srl
Gastroenterology & Urology · 99d
Cleared Apr 09, 2008
THD DISPOSABLE ANOSCOPE/PROCTOSCOPE
K080132
Thd Spa
Gastroenterology & Urology · 82d
Cleared Aug 10, 2007
SELF-LIGHT DISPOSABLE ANOSCOPE
K070913
Sapimed S.P.A.
Gastroenterology & Urology · 130d
Cleared Sep 06, 2006
SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE
K060623
Cook Ireland, Ltd.
Gastroenterology & Urology · 182d
Cleared Mar 29, 2002
O'REGAN DISPOSABLE ANOSCOPE
K020702
Canadian Theatre Products , Ltd.
Gastroenterology & Urology · 25d
Cleared Jul 11, 2001
RECTOSIGHT RS300-04
K011825
Sightline Technologies , Ltd.
Gastroenterology & Urology · 30d
Cleared Jun 30, 2000
RECTOSIGHT RS 300-04
K994130
Sightline Technologies , Ltd.
Gastroenterology & Urology · 206d
Cleared Jan 06, 2000
DISPOS-A-SCOPE
K993738
Dispos-A-Scope
Gastroenterology & Urology · 63d
Cleared Jan 21, 1993
INMAN MEDICAL PACKING STRIP
K921291
Inman Medical Corp.
Gastroenterology & Urology · 316d
Cleared Sep 12, 1988
ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL
K881469
Baxter Healthcare Corp
Gastroenterology & Urology · 158d
Cleared Jun 13, 1986
GALENICA'S DISPOSABLE ANOSCOPES
K861017
Galenica Enterprises, Inc.
Gastroenterology & Urology · 87d

About Product Code FER - Regulatory Context

510(k) Submission Activity

27 total 510(k) submissions under product code FER since 1977, with 27 receiving FDA clearance (average review time: 118 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - FER Product Code

Recent submissions under FER have taken an average of 159 days to reach a decision - up from 114 days historically. Manufacturers should account for longer review timelines in current project planning.

FER devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →