K180026 is an FDA 510(k) clearance for the Bowel Management Device, Bowel Management Irrigation Set. 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 June 1, 2018, 149 days after receiving the submission on January 3, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K180026 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | January 03, 2018 |
| Decision Date | June 01, 2018 |
| Days to Decision | 149 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 |