KNTClass II
Tubes, Gastrointestinal (And Accessories)
21 CFR 876.5980 / Gastroenterology, Urology
KNT is the FDA product code for Tubes, Gastrointestinal (And Accessories), a class II device type, regulated under 21 CFR 876.5980. As of , FDA records hold 651 510(k) clearances under this code, the most recent dated , and 268 recalls.
Classification record
- Product code
- KNT
- Device name
- Tubes, Gastrointestinal (And Accessories)
- Regulation
- 21 CFR 876.5980
- 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
- 651
- Ingested recalls
- 268
Clearances, product code KNT
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1978 | 1 |
| 1979 | 7 |
| 1980 | 15 |
| 1981 | 19 |
| 1982 | 25 |
| 1983 | 39 |
| 1984 | 36 |
| 1985 | 28 |
| 1986 | 26 |
| 1987 | 19 |
| 1988 | 28 |
| 1989 | 20 |
| 1990 | 30 |
| 1991 | 13 |
| 1992 | 11 |
| 1993 | 17 |
| 1994 | 24 |
| 1995 | 19 |
| 1996 | 15 |
| 1997 | 10 |
| 1998 | 14 |
| 1999 | 14 |
| 2000 | 4 |
| 2001 | 11 |
| 2002 | 13 |
| 2003 | 6 |
| 2004 | 11 |
| 2005 | 7 |
| 2006 | 2 |
| 2007 | 10 |
| 2008 | 10 |
| 2009 | 11 |
| 2010 | 12 |
| 2011 | 7 |
| 2012 | 12 |
| 2013 | 7 |
| 2014 | 16 |
| 2015 | 10 |
| 2016 | 6 |
| 2017 | 9 |
| 2018 | 7 |
| 2019 | 10 |
| 2020 | 5 |
| 2021 | 6 |
| 2022 | 7 |
| 2023 | 5 |
| 2024 | 9 |
| 2025 | 4 |
| 2026 | 2 |
Applicants with the most clearances
Product code KNT| Applicant | Clearances |
|---|---|
| Biosearch Medical Products, Inc. | 35 |
| Abbott Medical | 26 |
| Medical Innovations, Inc. | 18 |
| Applied Medical Technology Inc | 16 |
| Halyard Health | 16 |
| C.R. Bard Inc | 15 |
| Wilson-Cook Medical Inc. | 12 |
| Sandoz Nutrition | 11 |
| Applied Medical Technologies | 10 |
| Boston Scientific Corporation | 10 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
