Anoscope And Accessories
The Anoscope and Accessories is a rigid tubular instrument used to examine and perform procedures within the anus and rectum, enabling direct visualization of the anal canal for diagnostic and therapeutic interventions. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is FER, regulated under 21 CFR 876.1500, within the Gastroenterology, Urology specialty.
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Basic Information
- Product Code
- FER
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
To examine and perform procedures within the anus and rectum.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 27 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250645 | SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) | Oct 09, 2025 | Substantially Equivalent | Haemoband Surgical, Ltd. |
| K242668 | Gastro Concepts Air Assist | Dec 13, 2024 | Substantially Equivalent | Gastro Concepts, LLC |
| K230439 | WellCare Anoscope | Dec 22, 2023 | Substantially Equivalent | Well Care (Wuhan) Medical Technology Co., Ltd. |
| K200021 | Applied Medical Anoscope | Jan 06, 2021 | Substantially Equivalent | Applied Medical Resources |
| K171701 | GelPOINT Path Transanal Access Platform | Jul 20, 2017 | Substantially Equivalent | Applied Medical Resources Corp. |
| K133393 | GELPOINT PATH TRANSANAL ACCESS PLATFORM | Jan 02, 2014 | Substantially Equivalent | Applied Medical Resources Corp. |
| K133687 | THD N-ANO ANOSCOPE | Dec 11, 2013 | Substantially Equivalent | Thd Spa |
| K121604 | ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT | Jul 27, 2012 | Substantially Equivalent | Obp Corporation |
| K121135 | THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE | Jun 01, 2012 | Substantially Equivalent | Thd Spa |
| K110792 | GELPOINT PATH | May 23, 2011 | Substantially Equivalent | Applied Medical Resources Corp. |
| K103647 | THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES | Mar 01, 2011 | Substantially Equivalent | Thd Spa |
| K093896 | ETHICON ENDO SURGERY SLOTTED ANOSCOPE | Mar 25, 2010 | Substantially Equivalent | Ethicon Endo-Surgery, Inc. |
| K091490 | FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES | Jun 11, 2009 | Substantially Equivalent | Thd Spa |
| K090432 | HEMORPEX SYSTEM | May 29, 2009 | Substantially Equivalent | Angiologica B. M. Srl |
| K080132 | THD DISPOSABLE ANOSCOPE/PROCTOSCOPE | Apr 09, 2008 | Substantially Equivalent | Thd Spa |
| K070913 | SELF-LIGHT DISPOSABLE ANOSCOPE | Aug 10, 2007 | Substantially Equivalent | Sapimed S.P.A. |
| K060623 | SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE | Sep 06, 2006 | Substantially Equivalent | Cook Ireland, Ltd. |
| K020702 | O'REGAN DISPOSABLE ANOSCOPE | Mar 29, 2002 | Substantially Equivalent | Canadian Theatre Products , Ltd. |
| K011825 | RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE | Jul 11, 2001 | Substantially Equivalent | Sightline Technologies , Ltd. |
| K994130 | RECTOSIGHT RS 300-04 | Jun 30, 2000 | Substantially Equivalent | Sightline Technologies , Ltd. |
| K993738 | DISPOS-A-SCOPE | Jan 06, 2000 | Substantially Equivalent | Dispos-A-Scope |
| K921291 | INMAN MEDICAL PACKING STRIP | Jan 21, 1993 | Substantially Equivalent | Inman Medical Corp. |
| K881469 | ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL | Sep 12, 1988 | Substantially Equivalent | Baxter Healthcare Corp |
| K861017 | GALENICA'S DISPOSABLE ANOSCOPES | Jun 13, 1986 | Substantially Equivalent | Galenica Enterprises, Inc. |
| K822085 | PRO-SCOPE | May 09, 1983 | Substantially Equivalent | Exitec, Inc. |
| K810227 | MODEL #53110 DISPOSABLE ANOSCOPE | Feb 19, 1981 | Substantially Equivalent | Welch Allyn, Inc. |
| K770906 | ANOSCOPE, OPTIC, FIBER | Jun 01, 1977 | Substantially Equivalent | Welch Allyn, Inc. |
FEI Numbers
This FDA classification entry is associated with 47 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 47 registration numbers. Click on an entry to view related FDA registrations.