Port, Protector/Cushion
The Port Protector/Cushion (product code OBK) is a general hospital device intended to cushion and protect the localized skin area surrounding an implanted subcutaneous or intravascular infusion port, reducing pressure and discomfort for patients with indwelling ports. It is used as an accessory for subjects who have implanted ports for long-term intravenous access. This device is FDA Class 2 under regulation 880.5965 in the General Hospital specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OBK
- Device Class
- FDA class 2
- Regulation Number
- 880.5965
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
Definition
Intended to cushion and protect the localized area surrounding the implanted port and indicated for subjects having implanted subcutaneous or intravascular infusion ports.
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 |
|---|---|---|---|---|
| K062261 | FOAM RING PORT PROTECTOR | Apr 09, 2007 | Substantially Equivalent | Inspired Ideas, Incorporated |