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 |