K120587 is an FDA 510(k) clearance for the AMT T-FASTENER ANCHOR KIT. This device is classified as a Tube, Gastro-enterostomy (Class II - Special Controls, product code KGC).
Submitted by Applied Medical Technology, Inc. (Brecksville, US). The FDA issued a Cleared decision on May 25, 2012, 88 days after receiving the submission on February 27, 2012.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K120587 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | February 27, 2012 |
| Decision Date | May 25, 2012 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| 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 |