OBK — Port, Protector/Cushion Class II
FDA product code OBK covers "Port, Protector/Cushion", a Class II medical device regulated under 21 CFR 880.5965. Submissions are reviewed by the General Hospital panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OBK
- Device Class
- Class II
- Regulation Number
- 880.5965
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
Intended to cushion and protect the localized area surrounding the implanted port and indicated for subjects having implanted subcutaneous or intravascular infusion ports.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K062261 | inspired ideas, incorporated | FOAM RING PORT PROTECTOR | April 9, 2007 |