FDA product code BWA: Unit, Electrosurgical And Coagulation, With Accessories
BWA is the FDA product code for unit, electrosurgical and coagulation, with accessories. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel. FDA has cleared 3 510(k) submissions under BWA, from 3 different applicants. The average 510(k) review took 107 days (median 63).
Classification
| Field | Value |
|---|---|
| Device name | Unit, Electrosurgical And Coagulation, With Accessories |
| Device class | Class II |
| Regulation | 21 CFR 878.4400 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every BWA clearance
Top BWA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alexander Mfg. Co. | 1 | 1997-04-17 |
| Valleylab, Inc. | 1 | 1987-12-14 |
| Zimmer Aspen Labs | 1 | 1987-11-20 |
Most recent BWA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K963305 | Alexander Mfg. Co. | ALEXANDER BOX, BATTERY, RECHARGEABLE | 1997-04-17 | 238 |
| K874794 | Valleylab, Inc. | E600B FOOTSWITCH | 1987-12-14 | 21 |
| K873809 | Zimmer Aspen Labs | EXCALIBUR ELECTROSURGICAL UNIT 60-5200-001 | 1987-11-20 | 63 |
Recalls for BWA devices
openFDA lists no recalls for product code BWA.
Frequently asked questions
What is FDA product code BWA?
BWA is the FDA product code for unit, electrosurgical and coagulation, with accessories. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel.
What device class is BWA?
Class II, regulation 21 CFR 878.4400. Typical premarket route: 510(k).
How long does a 510(k) take for product code BWA?
Across 3 cleared submissions the average was 107 days from receipt to decision (median 63).
Which companies have the most BWA clearances?
Alexander Mfg. Co. (1); Valleylab, Inc. (1); Zimmer Aspen Labs (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BWA
- Run a recall and safety report across every BWA manufacturer
- Watch product code BWA 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.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times