K073718 is an FDA 510(k) clearance for the MEDLINE GASTROSTOMY TUBE. This device is classified as a Tube, Gastro-enterostomy (Class II - Special Controls, product code KGC).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on March 19, 2008, 79 days after receiving the submission on December 31, 2007.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K073718 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 31, 2007 |
| Decision Date | March 19, 2008 |
| Days to Decision | 79 days |
| Submission Type | Abbreviated |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KGC — Tube, Gastro-enterostomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |