Sof-Flex Ureteral Stent Set
FDA 510(k) clearance K180053 · decided 2018-09-13
Clearance details
- K-number
- K180053
- Device name
- Sof-Flex Ureteral Stent Set
- Applicant
- Cook Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2018-01-08
- Decision date
- 2018-09-13
- Days to decision
- 248 days
- Clearance type
- Traditional
- Product code
- FAD
- Device class
- 2
- Regulation number
- 876.4620
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Bloomington, IN, 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S005) | Cook Incorporated | 2009-04-02 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S006) | Cook Incorporated | 2009-03-05 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S004) | Cook Incorporated | 2008-05-08 |
| COOK CHORIONIC VILLUS SAMPLING (CVS) SET (P900007/S002) | Cook Incorporated | 2000-06-12 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S001) | Cook Incorporated | 1998-07-08 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007) | Cook Incorporated | 1994-09-30 |