K900035 is an FDA 510(k) clearance for the WILSON-COOK COLON DECOMPRESSION SET. This device is classified as a Tube, Double Lumen For Intestinal Decompression And/or Intubation (Class II - Special Controls, product code FEG).
Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on March 7, 1990, 64 days after receiving the submission on January 2, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K900035 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 1990 |
| Decision Date | March 07, 1990 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FEG — Tube, Double Lumen For Intestinal Decompression And/or Intubation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |