The following data is part of a premarket notification filed by Aragon Surgical Inc. with the FDA for Aragon Surgical Rf System - 5mm Laparoscopic Instrument.
| Device ID | K110824 |
| 510k Number | K110824 |
| Device Name: | ARAGON SURGICAL RF SYSTEM - 5MM LAPAROSCOPIC INSTRUMENT |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ARAGON SURGICAL INC. 3617 SCOTT STREET San Francisco, CA 94123 |
| Contact | Alan Curtis |
| Correspondent | Alan Curtis ARAGON SURGICAL INC. 3617 SCOTT STREET San Francisco, CA 94123 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-23 |
| Decision Date | 2011-07-11 |
| Summary: | summary |