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510(k) K810007

PENTAX UPPER G.I. FIBERSCOPE, #FG-34 by Pentax Precision Instrument Corp. — Product Code GDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1981
Date Received
January 5, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Fiber Optic
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Pentax Precision Instrument Corp.

  • K041395 — EG-3630UR (June 9, 2004)
  • K041397 — EG-3830UT (June 9, 2004)
  • K041396 — FG-36UX FIBER ULTRASOUND GASTROSCOPE (June 9, 2004)
  • K031789 — EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE (August 8, 2003)
  • K023401 — EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE (February 11, 2003)
  • K023376 — EB-1830T3, VIDEO BRONCHOSCOPE (October 16, 2002)
  • K021276 — FG-36UX FIBER ULTRASOUND GASTROSCOPE (September 12, 2002)
  • K021278 — EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE (September 6, 2002)
  • K013640 — EG-3630UR, ULTRASUND VIDEO GASTROSCOPE (February 4, 2002)
  • K010740 — FG-36UX, FIBER ULTRASOUND GASTROSCOPE (April 17, 2001)

Other clearances for product code GDB

  • K032283 — DESIGNS FOR VISION FIBEROPTIC LIGHT (August 20, 2003)
  • K961536 — FLEXSCOPE (September 18, 1996)
  • K935818 — ENDOSCOPE (July 13, 1994)
  • K882061 — OLYMPUS GF-UM3/EU-M3 (November 15, 1988)
  • K855151 — FRITCH OPHTHALMIC ENDOSCOPE (February 19, 1986)
  • K843900 — FOCUSCOPE UNIVERSAL SYSTEM (December 6, 1984)