K102548 is an FDA 510(k) clearance for the FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE, a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT), submitted by Footprint Medical, Inc. (San Antonio, US). The FDA issued a Cleared decision on November 26, 2010, 84 days after receiving the submission on September 3, 2010. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K102548 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 03, 2010 |
| Decision Date | November 26, 2010 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNT — Tubes, Gastrointestinal (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5980 |