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 Applied Medical Resources Corp., Welch Allyn, Inc. and Ethicon Endo-Surgery, 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 May 23, 2011
GELPOINT PATH
K110792
Applied Medical Resources Corp.
Gastroenterology & Urology · 63d
Cleared Mar 25, 2010
ETHICON ENDO SURGERY SLOTTED ANOSCOPE
K093896
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 97d
Cleared Sep 12, 1988
ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL
K881469
Baxter Healthcare Corp
Gastroenterology & Urology · 158d
Cleared Feb 19, 1981
MODEL #53110 DISPOSABLE ANOSCOPE
K810227
Welch Allyn, Inc.
Chemistry · 23d
Cleared Jun 01, 1977
ANOSCOPE, OPTIC, FIBER
K770906
Welch Allyn, Inc.
Gastroenterology & Urology · 14d

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 →