FEDClass II
Endoscopic Access Overtube, Gastroenterology-Urology
21 CFR 876.1500 / Gastroenterology, Urology
FED is the FDA product code for Endoscopic Access Overtube, Gastroenterology-Urology, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation". As of , FDA records hold 102 510(k) clearances under this code, the most recent dated , and 12 recalls.
Classification record
- Product code
- FED
- Device name
- Endoscopic Access Overtube, Gastroenterology-Urology
- FDA definition
- To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.
- Regulation
- 21 CFR 876.1500
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 105
- Ingested recalls
- 12
Clearances, product code FED
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1982 | 1 |
| 1983 | 2 |
| 1984 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 2 |
| 1992 | 1 |
| 1994 | 2 |
| 1997 | 2 |
| 1998 | 1 |
| 1999 | 2 |
| 2000 | 1 |
| 2002 | 1 |
| 2003 | 5 |
| 2004 | 2 |
| 2005 | 5 |
| 2006 | 3 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 4 |
| 2010 | 3 |
| 2011 | 1 |
| 2012 | 4 |
| 2013 | 2 |
| 2014 | 4 |
| 2015 | 2 |
| 2016 | 5 |
| 2017 | 1 |
| 2018 | 4 |
| 2019 | 5 |
| 2020 | 4 |
| 2021 | 3 |
| 2022 | 1 |
| 2023 | 3 |
| 2024 | 6 |
| 2025 | 11 |
| 2026 | 5 |
Applicants with the most clearances
Product code FED| Applicant | Clearances |
|---|---|
| Boston Scientific Corporation | 7 |
| Usgi Medical | 6 |
| C.R. Bard Inc | 5 |
| MEDLINE INDUSTRIES, LP - Northfield | 5 |
| Boddingtons Plastics, Ltd. | 4 |
| Cook Incorporated | 4 |
| Neptune Medical, Inc | 4 |
| United States Endoscopy Group, Inc. | 4 |
| Applied Medical Resources Corp | 3 |
| Keymed, Inc. | 3 |
Companies listing this code with FDA
Companies whose registered establishments list this code- AD Supply Group Limited
- Advanced MedTech Corporate Pte Ltd
- Allwin Medical Devices, Inc.
- American Medical Endoscopy
- Aomori Olympus Co., Ltd. Hirosaki Site
- AOMORI OLYMPUS CO., Ltd. Kuroishi Site
- Applied Medical Distribution Center
- Applied Medical Europe
- Applied Medical Resources Corp
- Arvato SE
- Aspero Medical, Inc.
- Biomerics Fmi
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.