FDA product code PDW: Internal Tissue Marker
PDW is the FDA product code for internal tissue marker. It is a Class II device, regulated under 21 CFR 878.4670 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under PDW. The average 510(k) review took 78 days (median 78). 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Internal Tissue Marker |
| Device class | Class II |
| Regulation | 21 CFR 878.4670 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every PDW clearance
Top PDW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cianna Medical, Inc. | 2 | 2016-07-29 |
Most recent PDW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K161507 | Cianna Medical, Inc. | Cianna Medical SAVI Scout Reflector and SAVI Scout System | 2016-07-29 | 58 |
| K141318 | Cianna Medical, Inc. | CIANNA MEDICAL SGS SYSTEM | 2014-08-27 | 99 |
Recalls for PDW devices
openFDA lists no recalls for product code PDW.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- A4648 — Tissue marker, implantable, any type, each
Frequently asked questions
What is FDA product code PDW?
PDW is the FDA product code for internal tissue marker. It is a Class II device, regulated under 21 CFR 878.4670 and reviewed by the General and Plastic Surgery panel.
What device class is PDW?
Class II, regulation 21 CFR 878.4670. Typical premarket route: 510(k).
How long does a 510(k) take for product code PDW?
Across 2 cleared submissions the average was 78 days from receipt to decision (median 78).
Which companies have the most PDW clearances?
Cianna Medical, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code PDW
- Run a recall and safety report across every PDW manufacturer
- Watch product code PDW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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