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510(k) K951572

FS-38X, FIBER SIGMOIDOSCOPE by Pentax Precision Instrument Corp. — Product Code FAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1995
Date Received
April 4, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sigmoidoscope And Accessories, Flexible/Rigid
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

to examine and perform procedures within the sigmoid (descending) colon

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 FAM

  • K964131 — ENDOSCOPE (June 27, 1997)
  • K970382 — VS-100 VIDEO SIGMOIDOSCOPE (April 17, 1997)
  • K964326 — VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH (January 3, 1997)
  • K964100 — VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FI (December 16, 1996)
  • K963344 — DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOID (November 21, 1996)
  • K961567 — ES-3840, VIDEO SIGMOIDOSCOPE (June 24, 1996)
  • K951577 — ES-3800, VIDEO SIGMOIDOSCOPE (March 21, 1996)
  • K950429 — VIDEO SIGMOIDOSCOPE (August 1, 1995)
  • K951576 — FS-34P2, FIBER SIGMOIDOSCOPE (June 29, 1995)
  • K951573 — FS-38H, FIBER SIGMOIDOSCOPE (June 27, 1995)