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. Gastroenterology & Urology ✕

38 devices

1-12 of 38

Cleared Oct 10, 1996

ED-3410, VIDEO DUODENOSCOPE

Gastroenterology & Urology · 65d

Cleared Oct 04, 1996

EG-3400, VIDEO GASTROSCOPE

Gastroenterology & Urology · 71d

Cleared Sep 16, 1996

EG-3800T, VIDEO GASTROSCOPE

Gastroenterology & Urology · 83d

Cleared Jul 09, 1996

EG-2940, VIDEO GASTROSCOPE

Gastroenterology & Urology · 77d

Cleared Jul 09, 1996

Gastroenterology & Urology · 77d

Cleared Jun 24, 1996

ES-3840, VIDEO SIGMOIDOSCOPE

Gastroenterology & Urology · 62d

Cleared Jun 24, 1996

KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH)

Gastroenterology & Urology · 62d

Cleared Jun 19, 1996

EC-384OTL, VIDEO COLONSCOPE

Gastroenterology & Urology · 57d

Cleared Mar 21, 1996

EC-3800L, VIDEO COLONOSCOPE

Gastroenterology & Urology · 352d

Cleared Mar 21, 1996

ES-3800, VIDEO SIGMOIDOSCOPE

Gastroenterology & Urology · 352d

Cleared Mar 21, 1996

EC-3800TL, VIDEO COLONOSCOPE

Gastroenterology & Urology · 352d

Cleared Nov 03, 1995

FCP-9P, FIBER CHOLEDOCHOSCOPE

Gastroenterology & Urology · 113d

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