DISPOSABLE ELECTROSURGERY BALL ELECTRODE
FDA 510(k) clearance K925708 · decided 1993-04-20
Clearance details
- K-number
- K925708
- Device name
- DISPOSABLE ELECTROSURGERY BALL ELECTRODE
- Applicant
- Beacon Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-11-12
- Decision date
- 1993-04-20
- Days to decision
- 159 days
- Clearance type
- Traditional
- Product code
- DWG
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Broomfield, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MAHE INSTRUMENTS (K942823) | Mahe Intl., Inc. | 1994-12-05 |
| TECH-SWITCH ELECTROSURGICAL PENCIL, SINGLE USE (K932345) | Conmedcorp | 1994-04-12 |
| HAND-TROL S (K931215) | Aspen Labs | 1994-03-28 |
Recalls involving this device
No recalls on record reference this clearance.