The following data is part of a premarket notification filed by Cook Ireland Ltd. with the FDA for Echotip Ultra Endoscopic Ultrasound Needle, Echotip Procore Hd Ultrasound Biopsy Needle, Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle.
| Device ID | K210476 |
| 510k Number | K210476 |
| Device Name: | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, 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 V94n8x2 |
| Contact | Fay Dalton |
| Correspondent | Jane Kennedy Cook Ireland Ltd. O'Halloran Road, National Technology Park Limerick, IE V94n8x2 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-19 |
| Decision Date | 2021-05-20 |