EZLClass II
Catheter, Retention Type, Balloon
21 CFR 876.5130 / Gastroenterology, Urology
EZL is the FDA product code for Catheter, Retention Type, Balloon, a class II device type, regulated under 21 CFR 876.5130. As of , FDA records hold 129 510(k) clearances under this code, the most recent dated , and 85 recalls.
Classification record
- Product code
- EZL
- Device name
- Catheter, Retention Type, Balloon
- Regulation
- 21 CFR 876.5130
- 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
- Yes
- Ingested clearances
- 130
- Ingested recalls
- 85
Clearances, product code EZL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 2 |
| 1978 | 1 |
| 1981 | 1 |
| 1990 | 3 |
| 1991 | 1 |
| 1992 | 2 |
| 1993 | 1 |
| 1994 | 9 |
| 1995 | 6 |
| 1996 | 3 |
| 1997 | 6 |
| 1998 | 8 |
| 1999 | 4 |
| 2000 | 1 |
| 2001 | 4 |
| 2002 | 5 |
| 2003 | 6 |
| 2004 | 3 |
| 2005 | 3 |
| 2006 | 2 |
| 2007 | 7 |
| 2008 | 2 |
| 2009 | 4 |
| 2010 | 1 |
| 2011 | 2 |
| 2013 | 3 |
| 2014 | 2 |
| 2015 | 3 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 9 |
| 2019 | 3 |
| 2020 | 4 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 3 |
| 2024 | 5 |
| 2025 | 1 |
| 2026 | 3 |
Applicants with the most clearances
Product code EZL| Applicant | Clearances |
|---|---|
| C.R. Bard Inc | 10 |
| Regulatory & Marketing Services, Inc. | 6 |
| Amsino International, Inc. | 5 |
| Cook Incorporated | 4 |
| MEDLINE INDUSTRIES, LP - Northfield | 4 |
| Opticon Medical, Inc. | 4 |
| Rusch Intl. | 4 |
| Teleflexmedical, Inc. | 4 |
| Degania Silicone, Inc. | 3 |
| Rochester Medical Corp. | 3 |
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.