The following data is part of a premarket notification filed by Ximed/prosure/injectx with the FDA for Bipolar Electrosurgical Probes And Instruments.
| Device ID | K945995 |
| 510k Number | K945995 |
| Device Name: | BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | XIMED/PROSURE/INJECTX 2195 TRADE ZONE BLVD. San Jose, CA 95131 |
| Contact | Ashvin Desai |
| Correspondent | Ashvin Desai XIMED/PROSURE/INJECTX 2195 TRADE ZONE BLVD. San Jose, CA 95131 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-06 |
| Decision Date | 1995-01-31 |