FDA product code EXJ: Device, Incontinence, Urosheath Type, Sterile
EXJ is the FDA product code for device, incontinence, urosheath type, sterile. It is a Class I device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 22 510(k) submissions under EXJ, from 12 different applicants. The average 510(k) review took 102 days (median 60).
Classification
| Field | Value |
|---|---|
| Device name | Device, Incontinence, Urosheath Type, Sterile |
| Device class | Class I |
| Regulation | 21 CFR 876.5250 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EXJ clearance
Top EXJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sierra Laboratories, Inc. | 5 | 1997-04-22 |
| Convatec, A Division of E.R. Squibb & Sons | 3 | 1996-10-25 |
| Hollister, Inc. | 2 | 1996-09-16 |
| Rochester Medical Corp. | 2 | 1995-07-18 |
| Mentor Corp. | 2 | 1995-07-06 |
7 more applicants have EXJ clearances. See the full list in Caduvo.
Most recent EXJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K970465 | General Polymers | BOUSER'S URINAL | 1997-12-18 | 314 |
| K972100 | Advanced Care Medical Products | VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000) | 1997-07-31 | 57 |
| K970966 | Sierra Laboratories, Inc. | COMFORT CATH CHOICE MALE EXTERNAL CATHETER | 1997-04-22 | 36 |
| K963265 | Convatec, A Division of E.R. Squibb & Sons | PROSYS SAMEC LA | 1996-10-25 | 66 |
| K962900 | Hollister, Inc. | SELF RETAINING MALE EXTERNAL URINARY CATHETER | 1996-09-16 | 53 |
Recalls for EXJ devices
openFDA lists no recalls for product code EXJ.
Frequently asked questions
What is FDA product code EXJ?
EXJ is the FDA product code for device, incontinence, urosheath type, sterile. It is a Class I device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel.
What device class is EXJ?
Class I, regulation 21 CFR 876.5250. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EXJ?
Across 22 cleared submissions the average was 102 days from receipt to decision (median 60).
Which companies have the most EXJ clearances?
Sierra Laboratories, Inc. (5); Convatec, A Division of E.R. Squibb & Sons (3); Hollister, Inc. (2); Rochester Medical Corp. (2); Mentor Corp. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code EXJ
- Run a recall and safety report across every EXJ manufacturer
- Watch product code EXJ 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.
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