Internal Tissue Marker
The Internal Tissue Marker is a prescription-use surgical device intended for use prior to or during general surgical procedures to permanently mark an internal tissue site, such as a tumor bed or biopsy site, to guide subsequent treatment or re-excision. It falls under the General and Plastic Surgery medical specialty and is classified as a Class 2 device under regulation 878.4670, requiring 510(k) premarket notification. These markers provide surgeons and radiation oncologists with a durable reference point within the body for future procedures. It is not an implant itself and is not life-sustaining.
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Basic Information
- Product Code
- PDW
- Device Class
- FDA class 2
- Regulation Number
- 878.4670
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K161507 | Cianna Medical SAVI Scout Reflector and SAVI Scout System | Jul 29, 2016 | Substantially Equivalent | Cianna Medical, Inc. |
| DEN130004 | MOERAE SURGICAL MARKING PEN | Dec 18, 2014 | Unknown | Moerae Matrix, Inc. |
| K141318 | CIANNA MEDICAL SGS SYSTEM | Aug 27, 2014 | Substantially Equivalent | Cianna Medical, Inc. |