Electrosurgical Device
The Electrosurgical Device is a surgical instrument used in general and plastic surgery procedures to cut tissue and coagulate bleeding vessels by applying high-frequency electrical energy, reducing operative blood loss and enabling precise tissue dissection. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DWG and it is regulated under 21 CFR 878.4400 within the General, Plastic Surgery medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DWG
- Device Class
- FDA class 2
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K942823 | MAHE INSTRUMENTS | Dec 05, 1994 | Substantially Equivalent | Mahe Intl., Inc. |
| K932345 | TECH-SWITCH ELECTROSURGICAL PENCIL, SINGLE USE | Apr 12, 1994 | Substantially Equivalent | Conmedcorp |
| K931215 | HAND-TROL S | Mar 28, 1994 | Substantially Equivalent | Aspen Labs |
| K925708 | DISPOSABLE ELECTROSURGERY BALL ELECTRODE | Apr 20, 1993 | Substantially Equivalent | Beacon Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.