LJEUnclassified
Catheter, Nephrostomy
Unknown
LJE is the FDA product code for Catheter, Nephrostomy. As of , FDA records hold 56 510(k) clearances under this code, the most recent dated , and 12 recalls.
Classification record
- Product code
- LJE
- Device name
- Catheter, Nephrostomy
- Device class
- Unclassified
- Review panel
- Unknown
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 56
- Ingested recalls
- 12
Clearances, product code LJE
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1982 | 2 |
| 1983 | 4 |
| 1984 | 7 |
| 1985 | 4 |
| 1986 | 1 |
| 1989 | 1 |
| 1992 | 3 |
| 1995 | 5 |
| 1996 | 3 |
| 1998 | 4 |
| 1999 | 1 |
| 2001 | 1 |
| 2003 | 1 |
| 2005 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 3 |
| 2019 | 4 |
| 2020 | 2 |
| 2022 | 1 |
| 2023 | 1 |
| 2025 | 1 |
Applicants with the most clearances
Product code LJE| Applicant | Clearances |
|---|---|
| Cook Incorporated | 12 |
| Uresil, LLC | 5 |
| American Edwards Laboratories | 3 |
| Boston Scientific Corporation | 3 |
| C.R. Bard Inc | 3 |
| Argon Medical Devices, Inc | 3 |
| Medical Engineering Corp. | 3 |
| MEDLINE INDUSTRIES, LP - Northfield | 2 |
| E-Z-EM, Inc | 2 |
| Medical Device Technologies, Inc. | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this code- AD Supply Group Limited
- Allwin Medical Devices, Inc.
- Argon Medical Devices, Inc
- Atc Technologies Inc.
- Auris Health, Inc
- Biomerics Fmi
- Bioteque Corp.
- Bioteque Corporation Yilan Science Park Factory
- Boston Scientific Corporation
- C.R. Bard Inc
- CBR Enterprise Limited
- Centre de distribution Coloplast le Plessis Pate
FIRST ARTICLE / WEEKLY
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