Pentax Medical Company

FDA Regulatory Profile

Summary

Total Recalls
26 (1 Class I)
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2276-2016Class IIConfocal GI Scope Product Usage: Intended to provide optical visualization of and therapeutic acApril 6, 2016
Z-2080-2016Class IISmall Bowel Scope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the orgaApril 6, 2016
Z-2078-2016Class IIUreteroscope Intended to provide optical visualization of and therapeutic access to the Urinary TraApril 6, 2016
Z-2068-2016Class IIColonoscope Intended to provide optical visualization of and therapeutic access to the Lower GastroApril 6, 2016
Z-2067-2016Class IICholedochoscope Intended to provide optical visualization of and therapeutic access to the Biliary April 6, 2016
Z-2277-2016Class IIDuodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access April 6, 2016
Z-2079-2016Class IIEsophagoscope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, April 6, 2016
Z-2073-2016Class IILaryngo Stroboscope Product Usage Intended to provide optical visualization of, therapeutic access April 6, 2016
Z-2275-2016Class IIColonoscope Product Usage: Intended to provide optical visualization of and therapeutic access tApril 6, 2016
Z-2278-2016Class IIGastroscope Product Usage: Intended to provide optical visualization of and therapeutic access tApril 6, 2016
Z-2279-2016Class IIUltrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic VApril 6, 2016
Z-2071-2016Class IIGastroscope Intended to provide optical visualization of and therapeutic access to the Upper GastroApril 6, 2016
Z-2070-2016Class IICystoscope Intended to provide optical visualization of and therapeutic access to the Urinary TractApril 6, 2016
Z-2077-2016Class IIUltrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of anApril 6, 2016
Z-2065-2016Class IIBronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and April 6, 2016
Z-2072-2016Class IIIntubation Scope Intended to provide optical visualization of, therapeutic access to, and use to faApril 6, 2016
Z-2074-2016Class IINaso-Pharyngo-Laryngoscope Intended to provide optical visualization of, therapeutic access to, theApril 6, 2016
Z-2075-2016Class IISignmoidoscope Intended to provide optical visualization of, therapeutic access to, the Lower GastrApril 6, 2016
Z-2069-2016Class IIConfocal GI Scope Intended to provide optical visualization of an therapeutic access to the GastroiApril 6, 2016
Z-2066-2016Class IICholedocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the AApril 6, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K192280PENTAX Medical ED-3490TK Video DuodenoscopeOctober 21, 2019
K171011PENTAX Medical VIVIDEO ENT Videoscope SolutionJuly 18, 2018
K172156PENTAX Medical EPK-3000 Video Imaging SystemApril 5, 2018
K161222PENTAX MEDICAL ED-3490TK, Video DuodenoscopeFebruary 7, 2018
K163614PENTAX Medical ED34-i10T, Video DuodenoscopeSeptember 20, 2017
K131946ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUSApril 25, 2014
K131028PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)April 10, 2014
K131902PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)April 10, 2014
K131855PENTAX VIDEO COLONOSCOPES (EC FAMILY)April 9, 2014
K122470PENTAX EPK-I5010 VIDEO PROCESSORApril 10, 2013
K093037PENTEX EC-3890LIDecember 28, 2009
K092710PENTAX ED-3490TK, VIDEO DUODENOSCOPEDecember 2, 2009
K090196EG-3670URKMay 19, 2009
K090197EG-3870UTKMay 19, 2009
K081518ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UKSeptember 5, 2008
K061068EG-3670URKMay 3, 2006
K042740ISC-1000 PENTAX CONFOCAL LASER SYSTEMOctober 19, 2004
K042741EC-3870CILK, CONFOCAL VIDEO COLONOSCOPEOctober 19, 2004