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510(k) K932843

FLEXIBLE VIDEO SIGMOIDOSCOPE SYSTEM W/DISP. SHEATH by Vision-Sciences, Inc. — Product Code FAM

K932843 is an FDA 510(k) premarket notification submitted by Vision-Sciences, Inc. for the device "FLEXIBLE VIDEO SIGMOIDOSCOPE SYSTEM W/DISP. SHEATH". The FDA issued a decision of Substantially Equivalent on February 14, 1994. The device falls under product code FAM (Sigmoidoscope And Accessories, Flexible/Rigid), a Class II device regulated under 21 CFR 876.1500. Vision-Sciences, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1994
Date Received
June 11, 1993
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 Vision-Sciences, Inc.

  • K102733 — VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIE (May 18, 2011)
  • K100125 — VISION SCIENCES FLEXIBLE ENT SCOPE (February 25, 2010)
  • K091768 — VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU- (August 3, 2009)
  • K072180 — VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM (December 18, 2007)
  • K071127 — FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM (November 16, 2007)
  • K072073 — VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DP (August 29, 2007)
  • K072088 — FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOS (August 29, 2007)
  • K071903 — ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE (August 2, 2007)
  • K053560 — MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE (March 16, 2006)
  • K050972 — VISION-SCIENCES ENT-3000 SCOPE (April 29, 2005)

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)
  • K951572 — FS-38X, FIBER SIGMOIDOSCOPE (June 27, 1995)

FDA data resources