Pentax Medical Company
FDA Regulatory Profile
Pentax Medical Company appears in FDA public data with 26 recalls — including 1 Class I (most serious) —, 18 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2071-2016, Class II) was initiated on April 6, 2016. Its most recent 510(k) clearance was granted on October 21, 2019.
Summary
- Total Recalls
- 26 (1 Class I)
- 510(k) Clearances
- 18
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2071-2016 | Class II | Gastroscope Intended to provide optical visualization of and therapeutic access to the Upper Gastro | April 6, 2016 |
| Z-2079-2016 | Class II | Esophagoscope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, | April 6, 2016 |
| Z-2068-2016 | Class II | Colonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastro | April 6, 2016 |
| Z-2080-2016 | Class II | Small Bowel Scope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the orga | April 6, 2016 |
| Z-2073-2016 | Class II | Laryngo Stroboscope Product Usage Intended to provide optical visualization of, therapeutic access | April 6, 2016 |
| Z-2074-2016 | Class II | Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of, therapeutic access to, the | April 6, 2016 |
| Z-2075-2016 | Class II | Signmoidoscope Intended to provide optical visualization of, therapeutic access to, the Lower Gastr | April 6, 2016 |
| Z-2078-2016 | Class II | Ureteroscope Intended to provide optical visualization of and therapeutic access to the Urinary Tra | April 6, 2016 |
| Z-2077-2016 | Class II | Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of an | April 6, 2016 |
| Z-2065-2016 | Class II | Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and | April 6, 2016 |
| Z-2069-2016 | Class II | Confocal GI Scope Intended to provide optical visualization of an therapeutic access to the Gastroi | April 6, 2016 |
| Z-2066-2016 | Class II | Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the A | April 6, 2016 |
| Z-2076-2016 | Class II | Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualization of a | April 6, 2016 |
| Z-2070-2016 | Class II | Cystoscope Intended to provide optical visualization of and therapeutic access to the Urinary Tract | April 6, 2016 |
| Z-2072-2016 | Class II | Intubation Scope Intended to provide optical visualization of, therapeutic access to, and use to fa | April 6, 2016 |
| Z-2067-2016 | Class II | Choledochoscope Intended to provide optical visualization of and therapeutic access to the Biliary | April 6, 2016 |
| Z-2275-2016 | Class II | Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access t | April 6, 2016 |
| Z-2278-2016 | Class II | Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access t | April 6, 2016 |
| Z-2276-2016 | Class II | Confocal GI Scope Product Usage: Intended to provide optical visualization of and therapeutic ac | April 6, 2016 |
| Z-2277-2016 | Class II | Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access | April 6, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K192280 | PENTAX Medical ED-3490TK Video Duodenoscope | October 21, 2019 |
| K171011 | PENTAX Medical VIVIDEO ENT Videoscope Solution | July 18, 2018 |
| K172156 | PENTAX Medical EPK-3000 Video Imaging System | April 5, 2018 |
| K161222 | PENTAX MEDICAL ED-3490TK, Video Duodenoscope | February 7, 2018 |
| K163614 | PENTAX Medical ED34-i10T, Video Duodenoscope | September 20, 2017 |
| K131946 | ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS | April 25, 2014 |
| K131028 | PENTAX VIDEO BRONCHOSCOPES (EB FAMILY) | April 10, 2014 |
| K131902 | PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY) | April 10, 2014 |
| K131855 | PENTAX VIDEO COLONOSCOPES (EC FAMILY) | April 9, 2014 |
| K122470 | PENTAX EPK-I5010 VIDEO PROCESSOR | April 10, 2013 |
| K093037 | PENTEX EC-3890LI | December 28, 2009 |
| K092710 | PENTAX ED-3490TK, VIDEO DUODENOSCOPE | December 2, 2009 |
| K090196 | EG-3670URK | May 19, 2009 |
| K090197 | EG-3870UTK | May 19, 2009 |
| K081518 | ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK | September 5, 2008 |
| K061068 | EG-3670URK | May 3, 2006 |
| K042741 | EC-3870CILK, CONFOCAL VIDEO COLONOSCOPE | October 19, 2004 |
| K042740 | ISC-1000 PENTAX CONFOCAL LASER SYSTEM | October 19, 2004 |