PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23
FDA 510(k) clearance K850020 · decided 1985-07-09
Clearance details
- K-number
- K850020
- Device name
- PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23
- Applicant
- Pentax Precision Instrument Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-01-04
- Decision date
- 1985-07-09
- Days to decision
- 186 days
- Clearance type
- Traditional
- Product code
- FDS
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Orangeburg, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Gastroscope Intended to provide optical visualization of and therapeutic access to the Upp recall (Z-2071-2016) | Pentax Medical Company | 2016-06-28 |
| PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve recall (Z-2290-2014) | Pentax Medical Company | 2014-08-21 |
| PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes recall (Z-0084-2014) | Pentax Medical Company | 2013-10-28 |