OOW — Applicator For Rectal Suppository Class I
FDA product code OOW covers "Applicator For Rectal Suppository", a Class I medical device regulated under 21 CFR 876.4730. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OOW
- Device Class
- Class I
- Regulation Number
- 876.4730
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
Intended for use in the insertion of suppositories into the rectum
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K092829 | christcot medical | INSERTEASE | December 2, 2009 |