The following data is part of a premarket notification filed by Senorx, Inc. with the FDA for Es-2000 Shape Select Electrosurgical Scalpel.
| Device ID | K012799 |
| 510k Number | K012799 |
| Device Name: | ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SENORX, INC. 11 COLUMBIA, SUITE A Aliso Viejo, CA 92656 |
| Contact | Amy Boucly |
| Correspondent | Donald James Sherratt INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-08-21 |
| Decision Date | 2001-09-04 |
| Summary: | summary |