K161413 is an FDA 510(k) clearance for the Low Profile Balloon Feeding Device. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).
Submitted by Applied Medical Technology, Inc. (Brecksville, US). The FDA issued a Cleared decision on February 9, 2017, 262 days after receiving the submission on May 23, 2016.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K161413 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 2016 |
| Decision Date | February 09, 2017 |
| Days to Decision | 262 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNT — Tubes, Gastrointestinal (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |