URETRON MODEL URT
FDA 510(k) clearance K111058 · decided 2012-03-30
Clearance details
- K-number
- K111058
- Device name
- URETRON MODEL URT
- Applicant
- Med-Sonics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2011-04-18
- Decision date
- 2012-03-30
- Days to decision
- 347 days
- Clearance type
- Abbreviated
- Product code
- FFK
- Device class
- 2
- Regulation number
- 876.4480
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Erie, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.