URASSIST
FDA 510(k) clearance K062061 · decided 2006-10-05
Clearance details
- K-number
- K062061
- Device name
- URASSIST
- Applicant
- Preferred Medical Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-07-20
- Decision date
- 2006-10-05
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- NZU
- Device class
- 1
- Regulation number
- 876.5250
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Kittery, ME, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.