Lehman Manometry Catheter— 510(k) K160170
Substantially EquivalentWilson-Cook Medical, Inc.
FDA 510(k) clearance K160170 for Lehman Manometry Catheter, Substantially Equivalent on 2016-06-20. Applicant: Wilson-Cook Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Wilson-Cook Medical, Inc.
- Product code
- Code FFX
- Device class
- Class 2
- Regulation
- 21 CFR 876.1725
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Winston-Salem, NC, US
Recent devices under product code FFX
view allMore clearances from Wilson-Cook Medical, Inc.
view allAdverse events under product code FFX
product code FFX- 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 →
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