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
| Device Type ID | 1397 |
| Device Name | Catheter, Drainage, Intraoral/extraoral |
| Physical State | It Is A Flexible, Single Lumen, Disposable Drainage Cannula Made Of Radio-opaque Polyurethane Material |
| Technical Method | The Drainage Cannula Is Inserted Which Allows The Fluid To Drain Following Endoscopic Removal Of Salivary Gland Stones |
| Target Area | Salivary Gland |
| Regulation Description | Introduction/drainage Catheter And Accessories. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | Dental |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4200 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OAJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1397 |
| Device | Catheter, Drainage, Intraoral/extraoral |
| Product Code | OAJ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Introduction/drainage Catheter And Accessories. |
| CFR Regulation Number | 878.4200 [🔎] |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 1 |