The following data is part of a premarket notification filed by Cook Ireland Ltd with the FDA for Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-hd-19a.
| Device ID | K092359 |
| 510k Number | K092359 |
| Device Name: | ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A |
| Classification | Biopsy Needle |
| Applicant | COOK IRELAND LTD O'HALLORAN ROAD NATIONAL TECHNOLOGY PARK Limerick, IE |
| Contact | Tracy Moriarty |
| Correspondent | Tracy Moriarty 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 | 2009-08-04 |
| Decision Date | 2009-11-02 |
| Summary: | summary |