510(k) K042132 ยท NVJ Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women
NOVASYS TRANSURETHRAL RF SYSTEM
| Applicant | Novasys Medical, Inc., Newark CA, US |
| Decision | Substantially Equivalent, Dec 21, 2004 |
| Received | Aug 9, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042132
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 16, 2010 | Novasys Medical Inc Renessa RF System, model PR0918, manufactured by Novasys Medical, Newark, CA Terminated |
NVJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.