FDA product code EXE: Protector, Ostomy
EXE is the FDA product code for protector, ostomy. It is a Class I device, regulated under 21 CFR 876.5900 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under EXE, from 3 different applicants. The average 510(k) review took 106 days (median 90). FDA has posted 4 recalls for EXE devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Protector, Ostomy |
| Device class | Class I |
| Regulation | 21 CFR 876.5900 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Top EXE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Convatec, A Division of E.R. Squibb & Sons | 1 | 1991-03-06 |
| Howmedica Corp. | 1 | 1977-07-15 |
| Rudolfo T. Sanchez | 1 | 1977-01-26 |
Most recent EXE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K904233 | Convatec, A Division of E.R. Squibb & Sons | CONVATEC ABSORBENT BANDAGE | 1991-03-06 | 182 |
| K770982 | Howmedica Corp. | UNITED SKIN BARRIER | 1977-07-15 | 45 |
| K760927 | Rudolfo T. Sanchez | STOMA SHIELD ADAPTER | 1977-01-26 | 90 |
Recalls for EXE devices
4 product recalls in 4 recall events; 3 initiated in the last five years and 2 still open. Most recent: 2024-11-29.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2022 | 1 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code EXE?
EXE is the FDA product code for protector, ostomy. It is a Class I device, regulated under 21 CFR 876.5900 and reviewed by the Gastroenterology and Urology panel.
What device class is EXE?
Class I, regulation 21 CFR 876.5900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EXE?
Across 3 cleared submissions the average was 106 days from receipt to decision (median 90).
Which companies have the most EXE clearances?
Convatec, A Division of E.R. Squibb & Sons (1); Howmedica Corp. (1); Rudolfo T. Sanchez (1).
Have EXE devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2024-11-29.
Next steps
- Run an FDA pathway report with predicate devices for product code EXE
- Run a recall and safety report across every EXE manufacturer
- Watch product code EXE 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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