PDW
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Internal Tissue Marker
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4670
- Medical specialty
- General, Plastic Surgery
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Cianna Medical SAVI Scout Reflector and SAVI Scout System (K161507) | Cianna Medical, Inc. | 2016-07-29 |
| MOERAE SURGICAL MARKING PEN (DEN130004) | Moerae Matrix, Inc. | 2014-12-18 |
| CIANNA MEDICAL SGS SYSTEM (K141318) | Cianna Medical, Inc. | 2014-08-27 |
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Every clearance here is in the API, with alerts when new ones post.