K120182 is an FDA 510(k) clearance for the NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES, a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT), submitted by Neomed, Inc. (Swanee, US). The FDA issued a Cleared decision on April 19, 2012, 90 days after receiving the submission on January 20, 2012. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K120182 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 20, 2012 |
| Decision Date | April 19, 2012 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNT — Tubes, Gastrointestinal (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5980 |