Novasys Medical, Inc.
Sunnyvale, CA, US
Novasys Medical, Inc. appears in FDA device records in Sunnyvale, CA. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Novasys Medical, Inc. between 2000 and 2004. The busiest year on record is 2000, with 3. The most recent is 2004, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 3 |
| 2002 | 1 |
| 2004 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K042132 | NOVASYS TRANSURETHRAL RF SYSTEM | NVJ | Substantially Equivalent | |
| K013730 | ARIEL RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND ACCESSORIES | GEI | Substantially Equivalent | |
| K001328 | INTRODUCER SHEATH | FEC | Substantially Equivalent | |
| K001150 | ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON CATHETER, MODEL 40-4 NEEDLE BALLOON CATHETER, MODEL 60-6 NEE | GEI | Substantially Equivalent | |
| K001151 | ELECTROSURGICAL ELECTRODE FAMILY | GEI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1404-2010 | Renessa RF System, model PR0918, manufactured by Novasys Medical, Newark, CA | Instructions for Use (IFU) revision-- Because of complaints received by the firm of worsened stress incontinence symptoms 3-4 weeks after treatment, the instructions for use were revised to emphasize potential side effects. Although Novasys has not, to date, identified a device malfunction associated with the symptoms discussed above, the investigation over time shows that there is a correlation | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain