The following data is part of a premarket notification filed by Surgrx Inc with the FDA for Surgrx Enseal Vessel Sealing And Hemostasis System Including The Enseal Controller Adapter, Enseal Open And Laparoscopis.
| Device ID | K031133 |
| 510k Number | K031133 |
| Device Name: | SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL CONTROLLER ADAPTER, ENSEAL OPEN AND LAPAROSCOPIS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SURGRX INC 2629-B TERMINAL BLVD. Mountain View, CA 94043 |
| Contact | Linda Oleson |
| Correspondent | Elizabeth Drew UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-04-09 |
| Decision Date | 2003-07-03 |
| Summary: | summary |