Unit, Electrosurgical And Coagulation, With Accessories
The Unit, Electrosurgical and Coagulation, With Accessories is a powered device that uses high-frequency electrical current to cut tissue and control bleeding through coagulation during surgical procedures. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is BWA, regulated under 21 CFR 878.4400 in the General and Plastic Surgery specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- BWA
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K963305 | ALEXANDER BOX, BATTERY, RECHARGEABLE | Apr 17, 1997 | Substantially Equivalent | Alexander Mfg. Co. |
| K874794 | E600B FOOTSWITCH | Dec 14, 1987 | Substantially Equivalent | Valleylab, Inc. |
| K873809 | EXCALIBUR ELECTROSURGICAL UNIT 60-5200-001 | Nov 20, 1987 | Substantially Equivalent | Zimmer Aspen Labs |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.