FDA product code DWI: Saw, Electrically Powered
DWI is the FDA product code for saw, electrically powered. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under DWI, from 2 different applicants. The average 510(k) review took 72 days (median 72).
Classification
| Field | Value |
|---|---|
| Device name | Saw, Electrically Powered |
| Device class | Class I |
| Regulation | 21 CFR 878.4820 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DWI clearance
Top DWI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Stryker Medical | 1 | 1991-07-30 |
| Temp Medical Products, Inc. | 1 | 1980-10-23 |
Most recent DWI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K912237 | Stryker Medical | STRYKER ECLIPSE WARMING STRETCHER | 1991-07-30 | 70 |
| K801914 | Temp Medical Products, Inc. | TEMP STERNUM SAW | 1980-10-23 | 73 |
Recalls for DWI devices
openFDA lists no recalls for product code DWI.
Frequently asked questions
What is FDA product code DWI?
DWI is the FDA product code for saw, electrically powered. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel.
What device class is DWI?
Class I, regulation 21 CFR 878.4820. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DWI?
Across 2 cleared submissions the average was 72 days from receipt to decision (median 72).
Which companies have the most DWI clearances?
Stryker Medical (1); Temp Medical Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DWI
- Run a recall and safety report across every DWI manufacturer
- Watch product code DWI 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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