FDA product code LWZ: Tissue Graft Of Less Than 6mm
LWZ is the FDA product code for tissue graft of less than 6mm. It is a Class III device, reviewed by the Cardiovascular panel. FDA has cleared 2 510(k) submissions under LWZ. The average 510(k) review took 17 days (median 17).
Classification
| Field | Value |
|---|---|
| Device name | Tissue Graft Of Less Than 6mm |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Compare with all 510(k) review times · Search every LWZ clearance
Top LWZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Eastman Kodak Company | 2 | 1984-08-27 |
Most recent LWZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K843149 | Eastman Kodak Company | KODAK T-MAT C FILM SO-119 | 1984-08-27 | 17 |
| K843148 | Eastman Kodak Company | KODAK T-MAT H FILM SO-118 | 1984-08-27 | 17 |
Recalls for LWZ devices
openFDA lists no recalls for product code LWZ.
Frequently asked questions
What is FDA product code LWZ?
LWZ is the FDA product code for tissue graft of less than 6mm. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is LWZ?
Class III. Typical premarket route: Contact FDA.
How long does a 510(k) take for product code LWZ?
Across 2 cleared submissions the average was 17 days from receipt to decision (median 17).
Which companies have the most LWZ clearances?
Eastman Kodak Company (2).
Next steps
- Run an FDA pathway report with predicate devices for product code LWZ
- Run a recall and safety report across every LWZ manufacturer
- Watch product code LWZ 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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