The following data is part of a premarket notification filed by Medtronic Advanced Energy, Llc with the FDA for Ec 2.7 Endoscopic Cutter.
| Device ID | K120909 |
| 510k Number | K120909 |
| Device Name: | EC 2.7 ENDOSCOPIC CUTTER |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEDTRONIC ADVANCED ENERGY, LLC 180 INTERNATIONAL DRIVE Portsmouth, NH 03801 |
| Contact | Martin J Leighton |
| Correspondent | Martin J Leighton MEDTRONIC ADVANCED ENERGY, LLC 180 INTERNATIONAL DRIVE Portsmouth, NH 03801 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-26 |
| Decision Date | 2012-11-02 |
| Summary: | summary |