NOVASYS TRANSURETHRAL RF SYSTEM
FDA 510(k) clearance K042132 · decided 2004-12-21
Clearance details
- K-number
- K042132
- Device name
- NOVASYS TRANSURETHRAL RF SYSTEM
- Applicant
- Novasys Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-08-09
- Decision date
- 2004-12-21
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- NVJ
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Newark, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Renessa RF System, model PR0918, manufactured by Novasys Medical, Newark, CA recall (Z-1404-2010) | Novasys Medical Inc | 2010-04-16 |