FDA product code LJE: Catheter, Nephrostomy
LJE is the FDA product code for catheter, nephrostomy. It is a Unclassified device, reviewed by the Gastroenterology and Urology panel. FDA has cleared 56 510(k) submissions under LJE, 3 in the last five years, from 28 different applicants. The average 510(k) review took 129 days (median 104); 135 days on average over the last three years. FDA has posted 12 recalls for LJE devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Nephrostomy |
| Device class | Unclassified |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for LJE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 59 |
| 2018 | 3 | 141 |
| 2019 | 4 | 243 |
| 2020 | 2 | 234 |
| 2022 | 1 | 262 |
| 2023 | 1 | 257 |
| 2025 | 1 | 135 |
Compare with all 510(k) review times · Search every LJE clearance
Top LJE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cook Incorporated | 8 | 2020-01-29 |
| Uresil Corp. | 5 | 1998-09-10 |
| Cook Urological, Inc. | 4 | 2003-02-27 |
| C.R. Bard, Inc. | 3 | 2008-10-23 |
| Manan Medical Products, Inc. | 3 | 1996-03-26 |
23 more applicants have LJE clearances. See the full list in Caduvo.
Most recent LJE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250448 | Shenzhen Trious Medical Technology Co., Ltd. | Disposable Percutaneous Nephrostomy Dilatation Kit | 2025-07-03 | 135 |
| K222705 | Youcare Technology Co.,Ltd. (Wuhan) | Introducer Needle | 2023-05-22 | 257 |
| K211911 | Coloplast Corp. | Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets | 2022-03-10 | 262 |
| K201165 | Coloplast Corp. | In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath | 2020-12-17 | 230 |
| K191498 | Cook Incorporated | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc | 2020-01-29 | 238 |
Recalls for LJE devices
12 product recalls in 9 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-10-17.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code LJE?
LJE is the FDA product code for catheter, nephrostomy. It is a Unclassified device, reviewed by the Gastroenterology and Urology panel.
What device class is LJE?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code LJE?
Across 56 cleared submissions the average was 129 days from receipt to decision (median 104).
Which companies have the most LJE clearances?
Cook Incorporated (8); Uresil Corp. (5); Cook Urological, Inc. (4); C.R. Bard, Inc. (3); Manan Medical Products, Inc. (3).
Have LJE devices been recalled?
Yes: 12 product recalls across 9 recall events; the most recent began 2025-10-17.
Next steps
- Run an FDA pathway report with predicate devices for product code LJE
- Run a recall and safety report across every LJE manufacturer
- Watch product code LJE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times