K083330 is an FDA 510(k) clearance for the ECHOTIP ULTRA ULTRASOUND NEEDLE, a Biopsy Needle (Class II — Special Controls, product code FCG), submitted by Cook Endoscopy (Winston-Salem, US). The FDA issued a Cleared decision on February 6, 2009, 86 days after receiving the submission on November 12, 2008. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K083330 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 12, 2008 |
| Decision Date | February 06, 2009 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FCG — Biopsy Needle |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1075 |