FDA product code LJH: System, Irrigation, Urological
LJH is the FDA product code for system, irrigation, urological. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 28 510(k) submissions under LJH, from 23 different applicants. The average 510(k) review took 120 days (median 89). FDA has posted 7 recalls for LJH devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Irrigation, Urological |
| Device class | Class II |
| Regulation | 21 CFR 876.5130 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LJH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 253 |
Top LJH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 4 | 1998-07-08 |
| Medical Scientific, Inc. | 2 | 2007-09-18 |
| Northgate Technologies, Inc. | 2 | 2000-08-18 |
| Karl Storz Endoscopy America, Inc. | 1 | 2017-07-07 |
| Amsino Intl., Inc. | 1 | 2007-12-19 |
18 more applicants have LJH clearances. See the full list in Caduvo.
Most recent LJH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K162992 | Karl Storz Endoscopy America, Inc. | Karl Storz UROMAT E.A.S.I. | 2017-07-07 | 253 |
| K070873 | Amsino Intl., Inc. | AMSURE BLADDER IRRIGATION SET | 2007-12-19 | 265 |
| K071832 | Medical Scientific, Inc. | MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM | 2007-09-18 | 77 |
| K063700 | Medical Scientific, Inc. | SPYGLASS IRRIGATION SYSTEM | 2007-02-08 | 57 |
| K062551 | Nexus Medical, LLC | NEXUS IRRIGATION TUBING SET | 2006-12-15 | 107 |
Recalls for LJH devices
7 product recalls in 4 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2022-08-19.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code LJH?
LJH is the FDA product code for system, irrigation, urological. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel.
What device class is LJH?
Class II, regulation 21 CFR 876.5130. Typical premarket route: 510(k).
How long does a 510(k) take for product code LJH?
Across 28 cleared submissions the average was 120 days from receipt to decision (median 89).
Which companies have the most LJH clearances?
KARL STORZ Endoscopy-America, Inc. (4); Medical Scientific, Inc. (2); Northgate Technologies, Inc. (2); Karl Storz Endoscopy America, Inc. (1); Amsino Intl., Inc. (1).
Have LJH devices been recalled?
Yes: 7 product recalls across 4 recall events; the most recent began 2022-08-19.
Next steps
- Run an FDA pathway report with predicate devices for product code LJH
- Run a recall and safety report across every LJH manufacturer
- Watch product code LJH 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