K924697 is an FDA 510(k) clearance for the FLEXIFLO LAPAROSCOPIC 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 August 27, 1993, 344 days after receiving the submission on September 17, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K924697 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | September 17, 1992 |
| Decision Date | August 27, 1993 |
| Days to Decision | 344 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 |