EASY CORE BIOPSY SYSTEM II
FDA 510(k) clearance K050120 · decided 2005-02-08
Clearance details
- K-number
- K050120
- Device name
- EASY CORE BIOPSY SYSTEM II
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2005-01-18
- Decision date
- 2005-02-08
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- FCG
- Device class
- 2
- Regulation number
- 876.1075
- 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.