PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520
FDA 510(k) clearance K093399 · decided 2009-11-19
Clearance details
- K-number
- K093399
- Device name
- PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520
- Applicant
- Inrad
- Decision
- Substantially Equivalent
- Date received
- 2009-11-02
- Decision date
- 2009-11-19
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- KNW
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Kentwood, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.