K171619 is an FDA 510(k) clearance for the 14Fr Colon Decompression Set, Macon Colon Decompression Set. This device is classified as a Tube, Double Lumen For Intestinal Decompression And/or Intubation (Class II - Special Controls, product code FEG).
Submitted by Cook Ireland, Ltd. (Limerick, IE). The FDA issued a Cleared decision on August 1, 2017, 60 days after receiving the submission on June 2, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K171619 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2017 |
| Decision Date | August 01, 2017 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FEG — Tube, Double Lumen For Intestinal Decompression And/or Intubation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |