ELECTROSURGICAL PENCIL
FDA 510(k) clearance K936304 · decided 1994-06-13
Clearance details
- K-number
- K936304
- Device name
- ELECTROSURGICAL PENCIL
- Applicant
- E & M Engineering, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-12-20
- Decision date
- 1994-06-13
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Richmond, VA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical. recall (Z-1990-2012) | PSC Industries Inc | 2012-07-11 |
| Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electr recall (Z-1991-2012) | PSC Industries Inc | 2012-07-11 |