Pentax Medical Company

• EOQ — Ear, Nose, Throat3 devices
• ODG — Gastroenterology, Urology3 devices
• FDF — Gastroenterology, Urology2 devices
• GCJ — Gastroenterology, Urology2 devices
• FDS — Gastroenterology, Urology1 device
• FDT — Gastroenterology, Urology1 device

• Z-2071-2016 — 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: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.Class II·Terminated·2016-04-06
• Z-2079-2016 — 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 when indications consistent with the need for procedure are observed in adult and pediatric patient populations.Class II·Terminated·2016-04-06
• Z-2068-2016 — 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: Large Bowel to the Cecum. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.Class II·Terminated·2016-04-06
• Z-2067-2016 — 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 Bile, Hepatic, Cystic and Pancreatic Ducts. The instrument is introduced via the working channel of a Duodenoscope positioned for access to the Common bile Duct when indications consistent with the need for procedure are observed in adult and pediatric patient populations.Class II·Terminated·2016-04-06
• Z-2080-2016 — 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 mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.Class II·Terminated·2016-04-06
• Z-2073-2016 — 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, tissues and subsystems: Larynx, Pharynx and Vocal Cords. 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.Class II·Terminated·2016-04-06
• Z-2074-2016 — 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: Ear, Nasal Passage and Trachea. 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 populationsClass II·Terminated·2016-04-06
• Z-2075-2016 — 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 subsystems: Large Bowel to the Sigmoid Colon. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populationsClass II·Terminated·2016-04-06
• Z-2078-2016 — 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, Bladder and Renal Pelvis. The instrument is introduced via the urethra when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.Class II·Terminated·2016-04-06
• Z-2077-2016 — 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, tissues and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced orally when indications consistent with the requirement for procedure are observed in adult and pediatricClass II·Terminated·2016-04-06

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K131946 — ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUSCode EOQ·2014-04-25
• K131028 — PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)Code EOQ·2014-04-10
• K131902 — PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)Code FDS·2014-04-10
• K131855 — PENTAX VIDEO COLONOSCOPES (EC FAMILY)Code FDF·2014-04-09
• K093037 — PENTEX EC-3890LICode FDF·2009-12-28
• K092710 — PENTAX ED-3490TK, VIDEO DUODENOSCOPECode FDT·2009-12-02
• K090196 — EG-3670URKCode ODG·2009-05-19
• K090197 — EG-3870UTKCode ODG·2009-05-19
• K081518 — ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UKCode EOQ·2008-09-05
• K061068 — EG-3670URKCode ODG·2006-05-03
• K042740 — ISC-1000 PENTAX CONFOCAL LASER SYSTEMCode GCJ·2004-10-19
• K042741 — EC-3870CILK, CONFOCAL VIDEO COLONOSCOPECode GCJ·2004-10-19