SUREFLEX LITHOTRIPSY LASER FIBERS
FDA 510(k) clearance K140679 · decided 2014-06-20
Clearance details
- K-number
- K140679
- Device name
- SUREFLEX LITHOTRIPSY LASER FIBERS
- Applicant
- American Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2014-03-18
- Decision date
- 2014-06-20
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Jose, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 200M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-bas recall (Z-2162-2015) | American Medical Systems Innovation Center - Silicon Valley | 2015-07-21 |
| 365M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-bas recall (Z-2163-2015) | American Medical Systems Innovation Center - Silicon Valley | 2015-07-21 |