K012476 is an FDA 510(k) clearance for the MONARCH, TRANSSHAPING GASTROSTOMY TUBE MODEL 9-2010. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).
Submitted by Applied Medical Technology, Inc. (Cleveland, US). The FDA issued a Cleared decision on August 31, 2001, 29 days after receiving the submission on August 2, 2001.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K012476 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2001 |
| Decision Date | August 31, 2001 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KNT — Tubes, Gastrointestinal (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |