K100712 is an FDA 510(k) clearance for the RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE. This device is classified as a Biopsy Needle (Class II - Special Controls, product code FCG).
Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on March 30, 2010, 18 days after receiving the submission on March 12, 2010.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K100712 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2010 |
| Decision Date | March 30, 2010 |
| Days to Decision | 18 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 |