FDA product code MAW: Marker, Suture Identification
MAW is the FDA product code for marker, suture identification. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under MAW. The average 510(k) review took 31 days (median 31).
Classification
| Field | Value |
|---|---|
| Device name | Marker, Suture Identification |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| 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 MAW clearance
Top MAW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Key Surgical, Inc. | 1 | 1989-12-14 |
Most recent MAW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K896472 | Key Surgical, Inc. | KEY VASCULAR BOOTIES | 1989-12-14 | 31 |
Recalls for MAW devices
openFDA lists no recalls for product code MAW.
Frequently asked questions
What is FDA product code MAW?
MAW is the FDA product code for marker, suture identification. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is MAW?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k).
How long does a 510(k) take for product code MAW?
Across 1 cleared submissions the average was 31 days from receipt to decision (median 31).
Which companies have the most MAW clearances?
Key Surgical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MAW
- Run a recall and safety report across every MAW manufacturer
- Watch product code MAW 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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