SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM
FDA 510(k) clearance K042136 · decided 2004-09-08
Clearance details
- K-number
- K042136
- Device name
- SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM
- Applicant
- Sanarus Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-08-09
- Decision date
- 2004-09-08
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- KNW
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Pleasanton, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.