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Pentax Precision Instrument Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
67
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K041397EG-3830UTJune 9, 2004
K041395EG-3630URJune 9, 2004
K041396FG-36UX FIBER ULTRASOUND GASTROSCOPEJune 9, 2004
K031789EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEAugust 8, 2003
K023401EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEFebruary 11, 2003
K023376EB-1830T3, VIDEO BRONCHOSCOPEOctober 16, 2002
K021276FG-36UX FIBER ULTRASOUND GASTROSCOPESeptember 12, 2002
K021278EG-3630UR, ULTRASOUND VIDEO GASTROSCOPESeptember 6, 2002
K013640EG-3630UR, ULTRASUND VIDEO GASTROSCOPEFebruary 4, 2002
K010740FG-36UX, FIBER ULTRASOUND GASTROSCOPEApril 17, 2001
K964815AP-4000, AIR PULSE SENSORY STIMULATORSeptember 4, 1997
K961974FG-36UX, ULTRASOUND UPPER GI FIBERSCOPEFebruary 10, 1997
K963056ED-3410, VIDEO DUODENOSCOPEOctober 10, 1996
K962897EG-3400, VIDEO GASTROSCOPEOctober 4, 1996
K962460EG-3800T, VIDEO GASTROSCOPESeptember 16, 1996
K961568ED-344OTJuly 9, 1996
K961564EG-2940, VIDEO GASTROSCOPEJuly 9, 1996
K961570KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH)June 24, 1996
K961567ES-3840, VIDEO SIGMOIDOSCOPEJune 24, 1996
K961563EC-384OTL, VIDEO COLONSCOPEJune 19, 1996