510(k) K023376 ยท EOQ Bronchoscope (Flexible Or Rigid)
EB-1830T3, VIDEO BRONCHOSCOPE
| Applicant | Pentax Precision Instrument Corp., Orangeburg NY, US |
| Decision | Substantially Equivalent, Oct 16, 2002 |
| Received | Oct 8, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023376
| 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 |
| Jan 20, 2012 | Pentax Medical Company EB- Series Video Bronchoscopes, EB-1570K & EB-1970K.
Intended to provide optical visualization of (via a video monitor), and therapeutic access to, the Pulmonary Tract. Terminated |
EOQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.