The following data is part of a premarket notification filed by Ximed/prosure/injectx with the FDA for Isolated Saline Electrodes/probes/devices-salinetrode.
| Device ID | K981256 |
| 510k Number | K981256 |
| Device Name: | ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE |
| Classification | Electrode, Electrosurgical, Active, Urological |
| Applicant | XIMED/PROSURE/INJECTX 2193 TRADE ZONE BLVD. San Jose, CA 95131 |
| Contact | Ashvin Desai |
| Correspondent | Ashvin Desai XIMED/PROSURE/INJECTX 2193 TRADE ZONE BLVD. San Jose, CA 95131 |
| Product Code | FAS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-02 |
| Decision Date | 1998-05-12 |