K971901 is an FDA 510(k) clearance for the RADIUS LOW PROFILE GASTROSTOMY TUBE KIT, a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT), submitted by Radius Intl., Inc. (Tarpon Springs, US). The FDA issued a Cleared decision on January 22, 1998, 244 days after receiving the submission on May 23, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K971901 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 23, 1997 |
| Decision Date | January 22, 1998 |
| Days to Decision | 244 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 |