Company ยท US
Pentax Medical Company
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2019. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
30recalls (0 in 12 months)
25recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | 6 |
| FDT | Duodenoscope And Accessories, Flexible/Rigid | 6 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 5 |
| GCJ | Laparoscope, General & Plastic Surgery | 4 |
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | 4 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 3 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 3 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 3 |
| EOX | Esophagoscope (Flexible Or Rigid) | 2 |
| FAM | Sigmoidoscope And Accessories, Flexible/Rigid | 2 |
| FBN | Choledochoscope And Accessories, Flexible/Rigid | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | 2 |
| CAL | Laryngoscope, Non-Rigid | 1 |
| EQL | Laryngostroboscope | 1 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 |
| FCX | Insufflator, Automatic Carbon-Dioxide For Endoscope | 1 |
| KOG | 1 | |
| PEA | Endoscope, Accessories, Image Post-Processing For Color Enhancement | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 21, 2019 | K192280 | PENTAX Medical ED-3490TK Video Duodenoscope Pentax Medical | FDT |
| Jul 18, 2018 | K171011 | PENTAX Medical VIVIDEO ENT Videoscope Solution Pentax Medical | EOB |
| Apr 5, 2018 | K172156 | PENTAX Medical EPK-3000 Video Imaging System Pentax Medical | EOB |
| Feb 7, 2018 | K161222 | PENTAX MEDICAL ED-3490TK, Video Duodenoscope Pentax Medical | FDT |
| Sep 20, 2017 | K163614 | PENTAX Medical ED34-i10T, Video Duodenoscope Pentax Medical | FDT |
| Apr 25, 2014 | K131946 | ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS Pentax Medical Company | EOQ |
| Apr 10, 2014 | K131902 | PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY) Pentax Medical Company | FDS |
| Apr 10, 2014 | K131028 | PENTAX VIDEO BRONCHOSCOPES (EB FAMILY) Pentax Medical Company | EOQ |
| Apr 9, 2014 | K131855 | PENTAX VIDEO COLONOSCOPES (EC FAMILY) Pentax Medical Company | FDF |
| Apr 10, 2013 | K122470 | PENTAX EPK-I5010 VIDEO PROCESSOR Pentax Medical | PEA |
| Dec 28, 2009 | K093037 | PENTEX EC-3890LI Pentax Medical Company | FDF |
| Dec 2, 2009 | K092710 | PENTAX ED-3490TK, VIDEO DUODENOSCOPE Pentax Medical Company | FDT |
| May 19, 2009 | K090197 | EG-3870UTK Pentax Medical Company | ODG |
| May 19, 2009 | K090196 | EG-3670URK Pentax Medical Company | ODG |
| Sep 5, 2008 | K081518 | ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK Pentax Medical Company | EOQ |
| May 3, 2006 | K061068 | EG-3670URK Pentax Medical Company | ODG |
| Oct 19, 2004 | K042741 | EC-3870CILK, CONFOCAL VIDEO COLONOSCOPE Pentax Medical Company | GCJ |
| Oct 19, 2004 | K042740 | ISC-1000 PENTAX CONFOCAL LASER SYSTEM Pentax Medical Company | GCJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2016 | Pentax Medical Company Signmoidoscope
Product Usage:
Intended to provide optical visualization of, therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissue Terminated |
FAM | K951572 |
| Jul 23, 2016 | Pentax Medical Company Ultrasound Gastroscope
Product Usage:
Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricte Terminated |
ODG | K961974 |
| Jul 23, 2016 | Pentax Medical Company Gastroscope
Product Usage:
Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissue Terminated |
FDF | K951574 |
| Jul 23, 2016 | Pentax Medical Company Duodenoscope
Product Usage:
Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; an Terminated |
FDT | K963056 |
| Jul 23, 2016 | Pentax Medical Company Confocal GI Scope
Product Usage:
Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissue Terminated |
GCJ | K042741 |
| Jul 23, 2016 | Pentax Medical Company Colonoscope
Product Usage:
Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissue Terminated |
FDF | K951574 |
| Jun 28, 2016 | Pentax Medical Company Small Bowel Scope
Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mou Terminated |
FGB | None listed |
| Jun 28, 2016 | Pentax Medical Company Esophagoscope
Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth w Terminated |
FGB | None listed |
| Jun 28, 2016 | Pentax Medical Company Ureteroscope
Intended to provide optical visualization of and therapeutic access to the Urinary Track. This anatomy includes but is not restricted to the organs, tissues and subsystems: Urethra, Bladd Terminated |
FGB | K914106 |
| Jun 28, 2016 | Pentax Medical Company Ultrasound Gastroscope
Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to organs, tis Terminated |
ITX | K961974 |
| 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 | K023376 K131028 +1 |
| Jun 28, 2016 | Pentax Medical Company Signmoidoscope
Intended to provide optical visualization of, therapeutic access to, the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystem Terminated |
FAM | K951572 K951577 |
| Jun 28, 2016 | Pentax Medical Company Naso-Pharyngo-Laryngoscope
Intended to provide optical visualization of, therapeutic access to, the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: E Terminated |
EOB | K921707 |
| Jun 28, 2016 | Pentax Medical Company Laryngo Stroboscope
Product Usage Intended to provide optical visualization of, therapeutic access to, the Upper Airway and Vocal Folds. This anatomy includes, but is not restricted to, the organs, ti Terminated |
EQL | None listed |
| Jun 28, 2016 | Pentax Medical Company Intubation Scope
Intended to provide optical visualization of, therapeutic access to, and use to facilitate routine or difficult tracheal intubations of the Upper Airway. This anatomy includes, but is Terminated |
CAL | None listed |
| Jun 28, 2016 | Pentax Medical Company Gastroscope
Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems Terminated |
FDS | K131902 K850020 +3 |
| Jun 28, 2016 | Pentax Medical Company Cystoscope
Intended to provide optical visualization of and therapeutic access to the Urinary Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Urethra to the Terminated |
FAJ | K914008 |
| Jun 28, 2016 | Pentax Medical Company Confocal GI Scope
Intended to provide optical visualization of an therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Terminated |
GCJ | K042741 |
| Jun 28, 2016 | Pentax Medical Company Colonoscope
Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems Terminated |
FDF | K131855 K951574 +3 |
| Jun 28, 2016 | Pentax Medical Company Choledochoscope
Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Common Bil Terminated |
FBN | K953286 |
| Jun 28, 2016 | Pentax Medical Company Choledocho-Nephroscope
Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Terminated |
FBN | K951191 |
| 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 | K023376 K131028 +1 |
| Feb 22, 2016 | Pentax Medical Company Video Duodenoscope Terminated |
FDT | K092770 |
| Aug 21, 2014 | Pentax Medical Company PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve Terminated |
KOG | K850020 |
| Jul 24, 2014 | Pentax Medical Company EG-3630U Ultrasound Video Gastroscope
EG-3830UT Ultrasound Video Gastroscope
EG-3870UTK Ultrasound Video Gastroscope
FG-36UX Ultrasound Fiber Gastroscope
Used to provide optical and sonographic visu Terminated |
FDS | K041396 K041397 |
| Oct 28, 2013 | Pentax Medical Company PENTAX Endoscopic Accessories. OF-B194. Made in Japan.
PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used Terminated |
FCX | K850020 |
| May 3, 2012 | Pentax Medical Company EG-3870UTK, Pentax Ultrasound Video Gastroscope.
The EG-3870UTK, Ultrasound Video Gastroscope, is intended to provide optical visualization via a video monitor of, ultrasonic visualization of, and th Terminated |
ITX | K090197 |
| Jan 20, 2012 | Pentax Medical Company EE- Series Video Naso Pharyngo Laryngo Scope, VNL-1570STK.
Intended to provide optical visualization (via a video monitor) of the Upper Airway. Terminated |
EOX | None listed |
| Jan 20, 2012 | Pentax Medical Company EE- Series Video Esophagoscopes, EE-1580K.
Intended to provide optical visualization of (via a video monitor) and therapeutic access to, the Upper Gastrointestinal Track. Terminated |
EOX | K961564 |
| 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 | K023376 |