The following data is part of a premarket notification filed by Cook Endoscopy with the FDA for Echotip Ultra Ultrasound Needle.
| Device ID | K083330 |
| 510k Number | K083330 |
| Device Name: | ECHOTIP ULTRA ULTRASOUND NEEDLE |
| Classification | Biopsy Needle |
| Applicant | COOK ENDOSCOPY 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem, NC 27105 |
| Contact | Scottie Fariole |
| Correspondent | Scottie Fariole COOK ENDOSCOPY 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem, NC 27105 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-12 |
| Decision Date | 2009-02-06 |
| Summary: | summary |