Atlas FDA

FER

27 FDA 510(k) clearances · Product code

82 daysmedian time to decision
304 days90th percentile
27clearances measured

FDA profile

Official device name
Anoscope And Accessories
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
FDA definition
To examine and perform procedures within the anus and rectum.
Adverse events (MAUDE)
2001: 1 · 2002: 1 · 2016: 14 · 2019: 15 · 2020: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) (K250645)Haemoband Surgical, Ltd.2025-10-09
Gastro Concepts Air Assist (K242668)Gastro Concepts, LLC2024-12-13
WellCare Anoscope (K230439)Well Care (Wuhan) Medical Technology Co., Ltd.2023-12-22
Applied Medical Anoscope (K200021)Applied Medical Resources2021-01-06
GelPOINT Path Transanal Access Platform (K171701)Applied Medical Resources Corp.2017-07-20
GELPOINT PATH TRANSANAL ACCESS PLATFORM (K133393)Applied Medical Resources Corp.2014-01-02
THD N-ANO ANOSCOPE (K133687)Thd Spa2013-12-11
ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT (K121604)Obp Corporation2012-07-27
THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE (K121135)Thd Spa2012-06-01
GELPOINT PATH (K110792)Applied Medical Resources Corp.2011-05-23
THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES (K103647)Thd Spa2011-03-01
ETHICON ENDO SURGERY SLOTTED ANOSCOPE (K093896)Ethicon Endo-Surgery, Inc.2010-03-25
FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES (K091490)Thd Spa2009-06-11
HEMORPEX SYSTEM (K090432)Angiologica B. M. Srl2009-05-29
THD DISPOSABLE ANOSCOPE/PROCTOSCOPE (K080132)Thd Spa2008-04-09
SELF-LIGHT DISPOSABLE ANOSCOPE (K070913)Sapimed S.P.A.2007-08-10
SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE (K060623)Cook Ireland, Ltd.2006-09-06
O'REGAN DISPOSABLE ANOSCOPE (K020702)Canadian Theatre Products , Ltd.2002-03-29
RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE (K011825)Sightline Technologies , Ltd.2001-07-11
RECTOSIGHT RS 300-04 (K994130)Sightline Technologies , Ltd.2000-06-30
DISPOS-A-SCOPE (K993738)Dispos-A-Scope2000-01-06
INMAN MEDICAL PACKING STRIP (K921291)Inman Medical Corp.1993-01-21
ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL (K881469)Baxter Healthcare Corp1988-09-12
GALENICA'S DISPOSABLE ANOSCOPES (K861017)Galenica Enterprises, Inc.1986-06-13
PRO-SCOPE (K822085)Exitec, Inc.1983-05-09
MODEL #53110 DISPOSABLE ANOSCOPE (K810227)Welch Allyn, Inc.1981-02-19
ANOSCOPE, OPTIC, FIBER (K770906)Welch Allyn, Inc.1977-06-01

Track FER automatically

Every clearance here is in the API, with alerts when new ones post.