FDA product code EXI: Device, Paste-On For Incontinence, Sterile
EXI is the FDA product code for device, paste-on for incontinence, sterile. It is a Class I device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 7 510(k) submissions under EXI, from 5 different applicants. The average 510(k) review took 106 days (median 100).
Classification
| Field | Value |
|---|---|
| Device name | Device, Paste-On For Incontinence, 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 EXI clearance
Top EXI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hollister, Inc. | 2 | 1997-02-25 |
| Convatec, A Division of E.R. Squibb & Sons | 2 | 1993-06-22 |
| Mediquest, Inc. | 1 | 1997-08-28 |
| Bioderm, Inc. | 1 | 1997-01-10 |
| Coloplast A/S | 1 | 1992-02-05 |
Most recent EXI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K971499 | Mediquest, Inc. | FEMALE EXTERNAL URINARY COLLECTION POUCH | 1997-08-28 | 125 |
| K970443 | Hollister, Inc. | HOLLISTER RETRACTED PENIS POUCH | 1997-02-25 | 20 |
| K963950 | Bioderm, Inc. | BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE | 1997-01-10 | 100 |
| K931277 | Hollister, Inc. | HOLLISTER PREMIUM URINE COLLECTOR | 1993-06-23 | 107 |
| K924755 | Convatec, A Division of E.R. Squibb & Sons | CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION | 1993-06-22 | 272 |
Recalls for EXI devices
openFDA lists no recalls for product code EXI.
Frequently asked questions
What is FDA product code EXI?
EXI is the FDA product code for device, paste-on for incontinence, 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 EXI?
Class I, regulation 21 CFR 876.5250. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EXI?
Across 7 cleared submissions the average was 106 days from receipt to decision (median 100).
Which companies have the most EXI clearances?
Hollister, Inc. (2); Convatec, A Division of E.R. Squibb & Sons (2); Mediquest, Inc. (1); Bioderm, Inc. (1); Coloplast A/S (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EXI
- Run a recall and safety report across every EXI manufacturer
- Watch product code EXI 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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