Pentax Precision Instrument Corp. - FDA 510(k) Cleared Devices
67
Total
67
Cleared
0
Denied
67 devices
Cleared
Jun 29, 1995
FS-34P2, FIBER SIGMOIDOSCOPE
Gastroenterology & Urology
86d
Cleared
Jun 27, 1995
FS-38X, FIBER SIGMOIDOSCOPE
Gastroenterology & Urology
84d
Cleared
Jun 27, 1995
FS-38H, FIBER SIGMOIDOSCOPE
Gastroenterology & Urology
84d
Cleared
Jun 27, 1995
FC-38TLH, FIBER COLONOSCOPE
Gastroenterology & Urology
84d
Cleared
Jun 27, 1995
FC-38LX, FIBER COLONOSCOPE
Gastroenterology & Urology
84d
Cleared
Jun 27, 1995
FC-38LH, FIBER COLONOSCCOPE
Gastroenterology & Urology
84d
Cleared
Jun 02, 1995
PENTAX FACE MASK
General Hospital
673d
Cleared
May 30, 1995
FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE
Gastroenterology & Urology
75d
Cleared
May 30, 1995
FE-24X, FIBER ESOPHAGOSCOPE
Gastroenterology & Urology
75d
Cleared
May 30, 1995
FE-34TH, FIBER ESOPHAGOSCOPE
Gastroenterology & Urology
75d
Cleared
Apr 10, 1995
FB-18X, FIBER BRONCHOSCOPE
Ear, Nose, Throat
25d
Cleared
Apr 07, 1995
FNL-10P, FIBER NASOPARHYNGOSCOPE
Ear, Nose, Throat
22d
Cleared
Apr 06, 1995
FI-10M
Anesthesiology
21d
Cleared
Apr 06, 1995
FI-10P
Anesthesiology
21d
Cleared
Feb 07, 1994
EPM-3300 VIDEO PROCESSOR
Gastroenterology & Urology
115d
Cleared
Jan 26, 1994
VB-1830/VB-1530, VIDEO BRONCHOSCOPE
Ear, Nose, Throat
103d
Cleared
Jun 25, 1993
PENTAX XENON LIGHT SOURCE
Gastroenterology & Urology
464d
Cleared
Jul 01, 1992
PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2
Ear, Nose, Throat
82d
Cleared
Jan 23, 1992
METAL HALIDE LIGHT SOURCE MODEL LM 250
General & Plastic Surgery
59d
Cleared
Jan 10, 1992
PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P
Gastroenterology & Urology
123d
Cleared
Jan 10, 1992
PENTAX URETERORENOFIBERSCOPE, MODEL FUR-10P
Gastroenterology & Urology
119d
Cleared
Jun 12, 1991
PENTAX ULTRASOUND ENDOSCOPE, MODEL FG-32UA
Radiology
246d
Cleared
Jul 09, 1985
PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23
Gastroenterology & Urology
186d
Cleared
Feb 04, 1984
TWO CHANNEL GASTROFIBERSCOPE FG-36T
Gastroenterology & Urology
82d
Cleared
Sep 20, 1983
LARYNGOTELESCOPE CURVED MLC-1
Ear, Nose, Throat
57d