Tri-Ex Extraction Balloon with Multiple Sizing
FDA 510(k) clearance K193344 · decided 2019-12-13
Clearance details
- K-number
- K193344
- Device name
- Tri-Ex Extraction Balloon with Multiple Sizing
- Applicant
- Wilson-Cook Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-12-03
- Decision date
- 2019-12-13
- Days to decision
- 10 days
- Clearance type
- Special
- Product code
- GCA
- Device class
- 2
- Regulation number
- 876.5010
- 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.