K132314 is an FDA 510(k) clearance for the MEDLINE ANTI-REFLUX VALVE. This device is classified as a Tube, Double Lumen For Intestinal Decompression And/or Intubation (Class II - Special Controls, product code FEG).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on September 18, 2013, 55 days after receiving the submission on July 25, 2013.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K132314 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2013 |
| Decision Date | September 18, 2013 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FEG — Tube, Double Lumen For Intestinal Decompression And/or Intubation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |