WILSON-COOK VARIABLE LENGTH GI INJECTION NEEDLE— 510(k) K941305
Substantially EquivalentWilson-Cook Medical, Inc.
FDA 510(k) clearance K941305 for WILSON-COOK VARIABLE LENGTH GI INJECTION NEEDLE, Substantially Equivalent on 1994-06-02. Applicant: Wilson-Cook Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Wilson-Cook Medical, Inc.
- Product code
- Code FBK
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Winston-Salem, NC, US
Recent devices under product code FBK
view allMore clearances from Wilson-Cook Medical, Inc.
view allAdverse events under product code FBK
product code FBK- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K941305
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K941305.
Data sourced from openFDA. This site is unofficial and independent of the FDA.