K031238 is an FDA 510(k) clearance for the VARICES NEEDLE, a Endoscopic Injection Needle, Gastroenterology-urology (Class II — Special Controls, product code FBK), submitted by Scandimed. A.S. (Collegeville, US). The FDA issued a Cleared decision on October 4, 2004, 535 days after receiving the submission on April 18, 2003. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K031238 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 18, 2003 |
| Decision Date | October 04, 2004 |
| Days to Decision | 535 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FBK — Endoscopic Injection Needle, Gastroenterology-urology |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | Inserted Through Endoscope For Injection Of A Solution, Gas, Or Implantable Materials Into Gi Or Gu Tissue. |