RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR
FDA 510(k) clearance K050232 · decided 2005-03-11
Clearance details
- K-number
- K050232
- Device name
- RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2005-02-01
- Decision date
- 2005-03-11
- Days to decision
- 38 days
- Clearance type
- Special
- Product code
- PID
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Natick,, MA, 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 |
|---|---|---|
| Wilson-Cook Achalasia Balloon (K182895) | Wilson-Cook Medical, Inc. | 2019-01-25 |
| ESOFLIP BALLOON DILATION CATHETER (K132337) | Crospon, Ltd. | 2013-10-07 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Produc recall (Z-1671-2013) | Boston Scientific Corporation | 2013-07-10 |