The following data is part of a premarket notification filed by Novasys Medical, Inc. with the FDA for Electrosurgical Electrode Family, Model 20-2 Needle Balloon Catheter, Model 40-4 Needle Balloon Catheter, Model 60-6 Nee.
| Device ID | K001150 |
| 510k Number | K001150 |
| Device Name: | ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON CATHETER, MODEL 40-4 NEEDLE BALLOON CATHETER, MODEL 60-6 NEE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | NOVASYS MEDICAL, INC. 687 NO. PASTORIA AVE. Sunnyvale, CA 94086 |
| Contact | Thamas Wehman |
| Correspondent | Thamas Wehman NOVASYS MEDICAL, INC. 687 NO. PASTORIA AVE. Sunnyvale, CA 94086 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-10 |
| Decision Date | 2000-06-29 |