PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)— 510(k) K131028
Substantially EquivalentPentax Medical Company
FDA 510(k) clearance K131028 for PENTAX VIDEO BRONCHOSCOPES (EB FAMILY), Substantially Equivalent on 2014-04-10. Applicant: Pentax Medical Company. Device class: 2.
Clearance details
- Applicant
- Pentax Medical Company
- Product code
- Code EOQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montvale, NJ, US
Recent devices under product code EOQ
view allMore clearances from Pentax Medical Company
view allAdverse events under product code EOQ
product code EOQ- Death
- 135
- Injury
- 2,863
- Malfunction
- 21,662
- Total
- 24,660
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K131028
K-number listed on FDA's recall record- Z-2875-2016 — 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 other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
- Z-2065-2016 — 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: Nasal Passage, Trachea and Bronchial Tree. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
- Z-2076-2016 — 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 subsystems: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations
- Z-2324-2017 — Video Bronchoscope
- Z-2325-2017 — Video Cytoscopes
- Z-2326-2017 — Video Naso pharyngo Laryngoscopes
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131028.
Data sourced from openFDA. This site is unofficial and independent of the FDA.