MICROVASIVE LITHOTRIPTOR FLEXPROBE II
FDA 510(k) clearance K002084 · decided 2000-07-19
Clearance details
- K-number
- K002084
- Device name
- MICROVASIVE LITHOTRIPTOR FLEXPROBE II
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2000-07-10
- Decision date
- 2000-07-19
- Days to decision
- 9 days
- Clearance type
- Special
- Product code
- FFK
- Device class
- 2
- Regulation number
- 876.4480
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Natick,, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.