Company ยท US
Novasys Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2004. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 21, 2004 | K042132 | NOVASYS TRANSURETHRAL RF SYSTEM Novasys Medical, Inc. | NVJ |
| Feb 6, 2002 | K013730 | ARIEL RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND ACCESSORIES Novasys Medical, Inc. | GEI |
| Jul 17, 2000 | K001328 | INTRODUCER SHEATH Novasys Medical, Inc. | FEC |
| Jun 29, 2000 | K001150 | ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON CATHETER, MODEL 40-4 NEEDLE BALLOON CATHETER, MODEL 60-6 NEE Novasys Medical, Inc. | GEI |
| Jun 27, 2000 | K001151 | ELECTROSURGICAL ELECTRODE FAMILY Novasys Medical, Inc. | GEI |
Latest recalls
| 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 | K042132 |