FDA product code OOW: Applicator For Rectal Suppository
OOW is the FDA product code for applicator for rectal suppository. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under OOW. The average 510(k) review took 78 days (median 78).
Definition
Intended for use in the insertion of suppositories into the rectum
Classification
| Field | Value |
|---|---|
| Device name | Applicator For Rectal Suppository |
| Device class | Class I |
| Regulation | 21 CFR 876.4730 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every OOW clearance
Top OOW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Christcot Medical Company | 1 | 2009-12-02 |
Most recent OOW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K092829 | Christcot Medical Company | INSERTEASE | 2009-12-02 | 78 |
Recalls for OOW devices
openFDA lists no recalls for product code OOW.
Frequently asked questions
What is FDA product code OOW?
OOW is the FDA product code for applicator for rectal suppository. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel.
What device class is OOW?
Class I, regulation 21 CFR 876.4730. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code OOW?
Across 1 cleared submissions the average was 78 days from receipt to decision (median 78).
Which companies have the most OOW clearances?
Christcot Medical Company (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OOW
- Run a recall and safety report across every OOW manufacturer
- Watch product code OOW 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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