WILSON-COOK COLON DECOMPRESSION SET
FDA 510(k) clearance K900035 · decided 1990-03-07
Clearance details
- K-number
- K900035
- Device name
- WILSON-COOK COLON DECOMPRESSION SET
- Applicant
- Wilson-Cook Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-01-02
- Decision date
- 1990-03-07
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- FEG
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Winston-Salem, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Model EMI 82691, Stic Kit Needle Containment Device. These devices are packaged 60 per cas recall (Z-0056-2007) | EM Innovations Inc | 2006-10-20 |
| Brodmerkel Colon Decompression Set, CDSB-10, Catheter Diameter: 10 Fr. Catheter Length: 35 recall (Z-0048-04) | Wilson-Cook Medical Inc | 2003-10-22 |