K901163 is an FDA 510(k) clearance for the WILSON-COOK PULL THROUGH PEG KIT. This device is classified as a Tube, Feeding (Class II - Special Controls, product code FPD).
Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on November 19, 1990, 251 days after receiving the submission on March 13, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K901163 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Direct De Novo (SESD) |
| Date Received | March 13, 1990 |
| Decision Date | November 19, 1990 |
| Days to Decision | 251 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FPD — Tube, Feeding |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |