The following data is part of a premarket notification filed by Cook Ireland Ltd with the FDA for Echotip Procore Hd Ultrasound Biopsy Needle.
| Device ID | K142688 |
| 510k Number | K142688 |
| Device Name: | Echotip Procore HD Ultrasound Biopsy Needle |
| Classification | Biopsy Needle |
| Applicant | COOK IRELAND LTD O'HALLORAN ROAD NATIONAL TECHNOLOGY PARK Limerick, IE |
| Contact | Nora O'connor |
| Correspondent | Nora O'connor COOK IRELAND LTD O'HALLORAN ROAD NATIONAL TECHNOLOGY PARK Limerick, IE |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-22 |
| Decision Date | 2014-12-19 |
| Summary: | summary |