FDA product code DWH: Blade, Saw, Surgical, Cardiovascular
DWH is the FDA product code for blade, saw, surgical, cardiovascular. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel. FDA has cleared 4 510(k) submissions under DWH, from 4 different applicants. The average 510(k) review took 40 days (median 40). FDA has posted 1 recall for DWH devices.
Classification
| Field | Value |
|---|---|
| Device name | Blade, Saw, Surgical, Cardiovascular |
| 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 DWH clearance
Top DWH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Codman & Shurtleff, Inc. | 1 | 1990-11-21 |
| Hall Surgical, Division of Zimmer, Inc. | 1 | 1986-07-17 |
| Micro-Aire Surgical Instruments, Inc. | 1 | 1985-03-01 |
| Temp Medical Products, Inc. | 1 | 1983-03-24 |
Most recent DWH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K904352 | Codman & Shurtleff, Inc. | CODMAN COLLINS RADIOPARENT STERNAL BLADES | 1990-11-21 | 58 |
| K862474 | Hall Surgical, Division of Zimmer, Inc. | HALL STERNUM SAW | 1986-07-17 | 17 |
| K850483 | Micro-Aire Surgical Instruments, Inc. | MICRO-AIRE STERNUM SAW REPLACEMENT BLADES | 1985-03-01 | 22 |
| K830189 | Temp Medical Products, Inc. | CARDIOVASCULAR SAW BLADES | 1983-03-24 | 64 |
Recalls for DWH devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-11-17.
Frequently asked questions
What is FDA product code DWH?
DWH is the FDA product code for blade, saw, surgical, cardiovascular. 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 DWH?
Class I, regulation 21 CFR 878.4820. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DWH?
Across 4 cleared submissions the average was 40 days from receipt to decision (median 40).
Which companies have the most DWH clearances?
Codman & Shurtleff, Inc. (1); Hall Surgical, Division of Zimmer, Inc. (1); Micro-Aire Surgical Instruments, Inc. (1); Temp Medical Products, Inc. (1).
Have DWH devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2011-11-17.
Next steps
- Run an FDA pathway report with predicate devices for product code DWH
- Run a recall and safety report across every DWH manufacturer
- Watch product code DWH 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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