FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE
FDA 510(k) clearance K951191 · decided 1995-05-30
Clearance details
- K-number
- K951191
- Device name
- FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE
- Applicant
- Pentax Precision Instrument Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-03-16
- Decision date
- 1995-05-30
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- FBN
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Miramar, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access recall (Z-2066-2016) | Pentax Medical Company | 2016-06-28 |