The following data is part of a premarket notification filed by Cook Ireland Ltd. with the FDA for Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle.
| Device ID | K160229 |
| 510k Number | K160229 |
| Device Name: | Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle |
| Classification | Biopsy Needle |
| Applicant | Cook Ireland Ltd. O' Halloran Road, National Technology Park, Limerick, IE |
| Contact | Lynsey Shine |
| Correspondent | Lynsey Shine 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 | 2016-02-01 |
| Decision Date | 2016-03-21 |
| Summary: | summary |