MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX TV SYSTEM)
FDA 510(k) clearance K020126 · decided 2002-03-15
Clearance details
- K-number
- K020126
- Device name
- MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX TV SYSTEM)
- Applicant
- Surx, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-01-15
- Decision date
- 2002-03-15
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- MUK
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Livermore, CA, 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 |
|---|---|---|
| SURX RF SYSTEM (K020952) | Surx, Inc. | 2002-05-30 |
| SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM) (K011190) | Surx, Inc. | 2002-01-08 |
Recalls involving this device
No recalls on record reference this clearance.