K912972 is an FDA 510(k) clearance for the FLEXIFLO OVER THE GUIDEWIRE JEJUNAL FEEDING TUBE. This device is classified as a Tube, Feeding (Class II - Special Controls, product code FPD).
Submitted by Abbott Laboratories (Columbus, US). The FDA issued a Cleared decision on September 23, 1991, 77 days after receiving the submission on July 8, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K912972 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 08, 1991 |
| Decision Date | September 23, 1991 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FPD — Tube, Feeding |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |