510(k) K131028 ยท EOQ Bronchoscope (Flexible Or Rigid)
PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)
| Applicant | Pentax Medical Company, Montvale NJ, US |
| Decision | Substantially Equivalent, Apr 10, 2014 |
| Received | Apr 12, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131028
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2016 | Pentax Medical Company Bronchoscope
Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Terminated |
EOQ | None listed |
| Jun 28, 2016 | Pentax Medical Company Ultrasound Bronchoscope
Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmonary Tract including but not restricted to organs, tissues and sub Terminated |
EOQ | None listed |
| May 31, 2016 | Pentax of America Inc Pentax Video Bronchoscope
Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and oth Terminated |
EOQ | None listed |
| Jan 11, 2011 | Pentax of America Inc Video Bronchoscope Terminated |
EOQ | None listed |
| Jan 11, 2011 | Pentax of America Inc Video Cytoscopes Terminated |
EOQ | None listed |
| Jan 11, 2011 | Pentax of America Inc Video Naso pharyngo Laryngoscopes Terminated |
EOQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.