K083802 is an FDA 510(k) clearance for the SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025, a Biopsy Needle (Class II — Special Controls, product code FCG), submitted by Medi-Globe Corporation (Tempe, US). The FDA issued a Cleared decision on March 20, 2009, 88 days after receiving the submission on December 22, 2008. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K083802 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 22, 2008 |
| Decision Date | March 20, 2009 |
| Days to Decision | 88 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 |