OAJClass I
Catheter, Drainage, Intraoral/Extraoral
21 CFR 878.4200 / General, Plastic Surgery
OAJ is the FDA product code for Catheter, Drainage, Intraoral/Extraoral, a class I device type, regulated under 21 CFR 878.4200. FDA's definition for this code reads: "To allow continuous drainage of saliva and/or fluid irrigation of the salivary duct as well as assisting in maintaining duct patency during the healing process following removal of salivary gland stones for temporary insertion into the salivary gland, whether orally or through the cheek following endoscopic or...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- OAJ
- Device name
- Catheter, Drainage, Intraoral/Extraoral
- FDA definition
- To allow continuous drainage of saliva and/or fluid irrigation of the salivary duct as well as assisting in maintaining duct patency during the healing process following removal of salivary gland stones for temporary insertion into the salivary gland, whether orally or through the cheek following endoscopic or surgical removal of salivary gland stones
- Regulation
- 21 CFR 878.4200
- Device class
- Class I
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code OAJ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2008 | 1 |
Applicants with the most clearances
Product code OAJ| Applicant | Clearances |
|---|---|
| Sialo Technology, Ltd. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.