The following data is part of a premarket notification filed by Surgrx, Inc. with the FDA for Surgrx Enseal Vessel Sealing & Hemostasis System.
| Device ID | K043008 |
| 510k Number | K043008 |
| Device Name: | SURGRX ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SURGRX, INC. 380 PORTAGE AVE. Palo Alto, CA 94306 |
| Contact | Linda Oleson |
| Correspondent | Linda Oleson SURGRX, INC. 380 PORTAGE AVE. Palo Alto, CA 94306 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-01 |
| Decision Date | 2004-11-17 |
| Summary: | summary |