Y WIRE 2
FDA 510(k) clearance K140576 · decided 2014-05-20
Clearance details
- K-number
- K140576
- Device name
- Y WIRE 2
- Applicant
- Safewire, LLC
- Decision
- Substantially Equivalent
- Date received
- 2014-03-06
- Decision date
- 2014-05-20
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- HXI
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Holland, MI, 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 |
|---|---|---|
| BOWEN KNOT PASSER (K863148) | Bowen & Company, Inc. | 1986-09-05 |
| BOWEN SUTURE PASSER (K863146) | Bowen & Company, Inc. | 1986-09-05 |
Recalls involving this device
No recalls on record reference this clearance.