PDW — Internal Tissue Marker Class II
FDA product code PDW covers "Internal Tissue Marker", a Class II medical device regulated under 21 CFR 878.4670. Submissions are reviewed by the General, Plastic Surgery panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PDW
- Device Class
- Class II
- Regulation Number
- 878.4670
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
An internal tissue marker is a prescription use device that is intended for use prior to or during general surgical procedures to demarcate selected sites on internal tissues.