Medical Device Manufacturer · US , Mchenry , IL

Pentax Precision Instrument Corp.

67 submissions · 67 cleared · Since 1979
67
Total
67
Cleared
0
Denied

Pentax Precision Instrument Corp. — FDA 510(k) Submissions

Pentax Precision Instrument Corp. has submitted 67 FDA 510(k) premarket notifications since 1979, of which 67 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Colonoscope And Accessories, Flexible/rigid, Bronchoscope (flexible Or Rigid), Endoscopic Ultrasound System, Gastroenterology-urology, Gastroscope And Accessories, Flexible/rigid, Sigmoidoscope And Accessories, Flexible/rigid . Use the specialty filter in the sidebar to narrow results.

67 devices
1–12 of 67
EG-3630UR
K041395 · ITX Transducer, Ultrasonic,... · Radiology
Jun 2004 14d
FG-36UX FIBER ULTRASOUND GASTROSCOPE
K041396 · ITX Transducer, Ultrasonic,... · Radiology
Jun 2004 14d
EG-3830UT
K041397 · ITX Transducer, Ultrasonic,... · Radiology
Jun 2004 14d
EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
K031789 · ODG Endoscopic Ultrasound... · Radiology
Aug 2003 59d
EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
K023401 · ODG Endoscopic Ultrasound... · Radiology
Feb 2003 125d
EB-1830T3, VIDEO BRONCHOSCOPE
K023376 · EOQ Bronchoscope (flexible Or... · Ear, Nose, Throat
Oct 2002 8d
FG-36UX FIBER ULTRASOUND GASTROSCOPE
K021276 · ODG Endoscopic Ultrasound... · Radiology
Sep 2002 143d
EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE
K021278 · ODG Endoscopic Ultrasound... · Radiology
Sep 2002 137d
EG-3630UR, ULTRASUND VIDEO GASTROSCOPE
K013640 · FDS Gastroscope And... · Radiology
Feb 2002 91d
FG-36UX, FIBER ULTRASOUND GASTROSCOPE
K010740 · ODG Endoscopic Ultrasound... · Radiology
Apr 2001 35d
AP-4000, AIR PULSE SENSORY STIMULATOR
K964815 · LLN Device, Vibration... · Neurology
Sep 1997 279d
FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE
K961974 · ITX Transducer, Ultrasonic,... · Radiology
Feb 1997 266d

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