K053410 is an FDA 510(k) clearance for the GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR. This device is classified as a Tube, Double Lumen For Intestinal Decompression And/or Intubation (Class II - Special Controls, product code FEG).
Submitted by Kendall (Mansfield, US). The FDA issued a Cleared decision on January 6, 2006, 30 days after receiving the submission on December 7, 2005.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K053410 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 2005 |
| Decision Date | January 06, 2006 |
| Days to Decision | 30 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 |