K915110 is an FDA 510(k) clearance for the FLEXIFLO OVER-THE-GUIDEWIRE GASTROSTOMY KIT. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).
Submitted by Abbott Laboratories (Columbus, US). The FDA issued a Cleared decision on April 14, 1992, 153 days after receiving the submission on November 13, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K915110 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | November 13, 1991 |
| Decision Date | April 14, 1992 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KNT — Tubes, Gastrointestinal (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |