Wilson-Cook Achalasia Balloon
FDA 510(k) clearance K182895 · decided 2019-01-25
Clearance details
- K-number
- K182895
- Device name
- Wilson-Cook Achalasia Balloon
- Applicant
- Wilson-Cook Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-10-15
- Decision date
- 2019-01-25
- Days to decision
- 102 days
- Clearance type
- Traditional
- Product code
- PID
- 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ESOFLIP BALLOON DILATION CATHETER (K132337) | Crospon, Ltd. | 2013-10-07 |
| RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR (K050232) | Boston Scientific Corp | 2005-03-11 |
Recalls involving this device
No recalls on record reference this clearance.