Catheter, Drainage, Intraoral/Extraoral
The Catheter, Drainage, Intraoral/Extraoral (product code OAJ) is a drainage catheter for temporary insertion into the salivary gland, either orally or through the cheek, to allow continuous drainage of saliva and fluid irrigation of the salivary duct, maintain duct patency during healing, and assist following endoscopic or surgical removal of salivary gland stones. It is classified as FDA Class 1, regulated under 21 CFR 878.4200 within the General and Plastic Surgery specialty. The device carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OAJ
- Device Class
- FDA class 1
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
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
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K072334 | SIALO DRAIN | Jul 18, 2008 | Substantially Equivalent | Sialo Technology, Ltd. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.