K992719 is an FDA 510(k) clearance for the AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE, a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT), submitted by Amsino Intl., Inc. (Pomona, US). The FDA issued a Cleared decision on January 12, 2000, 153 days after receiving the submission on August 12, 1999. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K992719 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 12, 1999 |
| Decision Date | January 12, 2000 |
| 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 |