K073034 is an FDA 510(k) clearance for the AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419). 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 March 14, 2008, 140 days after receiving the submission on October 26, 2007.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K073034 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | October 26, 2007 |
| Decision Date | March 14, 2008 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| 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 |