Medical Device Manufacturer · US , Mchenry , IL

Pentax Precision Instrument Corp. - FDA 510(k) Cleared Devices

67 submissions · 67 cleared · Since 1979

67

Total

67

Cleared

0

Denied

FDA 510(k) Regulatory Record - Pentax Precision Instrument Corp. Radiology ✕

12 devices

1-12 of 12

Cleared Jun 09, 2004

Radiology · 14d

Cleared Jun 09, 2004

FG-36UX FIBER ULTRASOUND GASTROSCOPE

Radiology · 14d

Cleared Jun 09, 2004

Radiology · 14d

Cleared Aug 08, 2003

EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE

Radiology · 59d

Cleared Feb 11, 2003

EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE

Radiology · 125d

Cleared Sep 12, 2002

FG-36UX FIBER ULTRASOUND GASTROSCOPE

Radiology · 143d

Cleared Sep 06, 2002

EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE

Radiology · 137d

Cleared Feb 04, 2002

EG-3630UR, ULTRASUND VIDEO GASTROSCOPE

Radiology · 91d

Cleared Apr 17, 2001

FG-36UX, FIBER ULTRASOUND GASTROSCOPE

Radiology · 35d

Cleared Feb 10, 1997

FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE

Radiology · 266d

Cleared Nov 24, 1995

PENTAX ULTRASOUND ENDOSCOPE MODEL FG-32UA (MODIFICATION)

Radiology · 109d

Cleared Jun 12, 1991

PENTAX ULTRASOUND ENDOSCOPE, MODEL FG-32UA

Radiology · 246d