PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)
FDA 510(k) clearance K131028 · decided 2014-04-10
Clearance details
- K-number
- K131028
- Device name
- PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)
- Applicant
- Pentax Medical Company
- Decision
- Substantially Equivalent
- Date received
- 2013-04-12
- Decision date
- 2014-04-10
- Days to decision
- 363 days
- Clearance type
- Traditional
- Product code
- EOQ
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Montvale, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bronchoscope Intended to provide optical visualization of and therapeutic access to the Ai recall (Z-2065-2016) | Pentax Medical Company | 2016-06-28 |
| Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualiza recall (Z-2076-2016) | Pentax Medical Company | 2016-06-28 |