Bronchi and Gastrointestinal Cytology Brush
FDA 510(k) clearance K171607 · decided 2017-07-31
Clearance details
- K-number
- K171607
- Device name
- Bronchi and Gastrointestinal Cytology Brush
- Applicant
- Wilson-Cook Medical Inc./Cook Endoscopy
- Decision
- Substantially Equivalent
- Date received
- 2017-06-01
- Decision date
- 2017-07-31
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- FDX
- Device class
- 2
- Regulation number
- 876.1500
- 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
No recalls on record reference this clearance.