K962554 is an FDA 510(k) clearance for the FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE. 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 November 7, 1997, 494 days after receiving the submission on July 1, 1996.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K962554 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 1996 |
| Decision Date | November 07, 1997 |
| Days to Decision | 494 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 |