FER — Anoscope And Accessories Class II
FDA product code FER covers "Anoscope And Accessories", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250645 | haemoband surgical | SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2 | October 9, 2025 |
| K242668 | gastro concepts | Gastro Concepts Air Assist | December 13, 2024 |
| K230439 | well care (wuhan) medical technology co | WellCare Anoscope | December 22, 2023 |
| K200021 | applied medical resources | Applied Medical Anoscope | January 6, 2021 |
| K171701 | applied medical resources | GelPOINT Path Transanal Access Platform | July 20, 2017 |
| K133393 | applied medical resources | GELPOINT PATH TRANSANAL ACCESS PLATFORM | January 2, 2014 |
| K133687 | thd | THD N-ANO ANOSCOPE | December 11, 2013 |
| K121604 | obp corporation | ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT | July 27, 2012 |
| K121135 | thd | THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE | June 1, 2012 |
| K110792 | applied medical resources | GELPOINT PATH | May 23, 2011 |
| K103647 | thd | THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES | March 1, 2011 |
| K093896 | ethicon endo-surgery | ETHICON ENDO SURGERY SLOTTED ANOSCOPE | March 25, 2010 |
| K091490 | thd | FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES | June 11, 2009 |
| K090432 | angiologica b. m | HEMORPEX SYSTEM | May 29, 2009 |
| K080132 | thd | THD DISPOSABLE ANOSCOPE/PROCTOSCOPE | April 9, 2008 |
| K070913 | sapimed | SELF-LIGHT DISPOSABLE ANOSCOPE | August 10, 2007 |
| K060623 | cook ireland | SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE | September 6, 2006 |
| K020702 | canadian theatre products | O'REGAN DISPOSABLE ANOSCOPE | March 29, 2002 |
| K011825 | sightline technologies | RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE | July 11, 2001 |
| K994130 | sightline technologies | RECTOSIGHT RS 300-04 | June 30, 2000 |