The following data is part of a premarket notification filed by Cook Ireland Ltd with the FDA for Plasmatrode Saline Safe Tur Electrode.
| Device ID | K122716 |
| 510k Number | K122716 |
| Device Name: | PLASMATRODE SALINE SAFE TUR ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | COOK IRELAND LTD O HALLORAN ROAD NATIONAL TECHNOLOGY PARK Limerick, IE 000 |
| Contact | Nora O'connor |
| Correspondent | Nora O'connor COOK IRELAND LTD O HALLORAN ROAD NATIONAL TECHNOLOGY PARK Limerick, IE 000 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-05 |
| Decision Date | 2013-04-17 |
| Summary: | summary |