K913476 is an FDA 510(k) clearance for the GI BLEEDER/OD SET. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).
Submitted by Icu Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on February 12, 1992, 191 days after receiving the submission on August 5, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K913476 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | August 05, 1991 |
| Decision Date | February 12, 1992 |
| Days to Decision | 191 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 |