FDA product code DWG: Electrosurgical Device
DWG is the FDA product code for electrosurgical device. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel. FDA has cleared 4 510(k) submissions under DWG, from 4 different applicants. The average 510(k) review took 262 days (median 254).
Classification
| Field | Value |
|---|---|
| Device name | Electrosurgical Device |
| 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 DWG clearance
Top DWG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mahe Intl., Inc. | 1 | 1994-12-05 |
| Conmedcorp | 1 | 1994-04-12 |
| Aspen Labs | 1 | 1994-03-28 |
| Beacon Laboratories, Inc. | 1 | 1993-04-20 |
Most recent DWG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K942823 | Mahe Intl., Inc. | MAHE INSTRUMENTS | 1994-12-05 | 174 |
| K932345 | Conmedcorp | TECH-SWITCH ELECTROSURGICAL PENCIL, SINGLE USE | 1994-04-12 | 333 |
| K931215 | Aspen Labs | HAND-TROL S | 1994-03-28 | 383 |
| K925708 | Beacon Laboratories, Inc. | DISPOSABLE ELECTROSURGERY BALL ELECTRODE | 1993-04-20 | 159 |
Recalls for DWG devices
openFDA lists no recalls for product code DWG.
Frequently asked questions
What is FDA product code DWG?
DWG is the FDA product code for electrosurgical device. 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 DWG?
Class II, regulation 21 CFR 878.4400. Typical premarket route: 510(k).
How long does a 510(k) take for product code DWG?
Across 4 cleared submissions the average was 262 days from receipt to decision (median 254).
Which companies have the most DWG clearances?
Mahe Intl., Inc. (1); Conmedcorp (1); Aspen Labs (1); Beacon Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DWG
- Run a recall and safety report across every DWG manufacturer
- Watch product code DWG 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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