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510(k) K970217

VISTA ILLUMINATION SYSTEM by Vista Medical Technologies, Inc. — Product Code FFS

K970217 is an FDA 510(k) premarket notification submitted by Vista Medical Technologies, Inc. for the device "VISTA ILLUMINATION SYSTEM". The FDA issued a decision of Substantially Equivalent on April 2, 1997. The device falls under product code FFS (Image, Illumination, Fiberoptic, For Endoscope), a Class II device regulated under 21 CFR 876.1500. Vista Medical Technologies, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1997
Date Received
January 21, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Image, Illumination, Fiberoptic, For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Vista Medical Technologies, Inc.

  • K021290 — VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE AC (June 28, 2002)
  • K020301 — MODIFICATION TO VISTA STEREOSCOPE SYSTEM (February 12, 2002)
  • K991303 — VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE (July 12, 1999)
  • K990635 — VISTA STEREOSCOPE SYSTEM (May 19, 1999)
  • K973436 — VISTA HEAD MOUNTED DISPLAY (December 9, 1997)
  • K971373 — VISTA SINGLE CHIP VIDEO CAMERA (May 20, 1997)
  • K961800 — HEAD MOUNTED DISPLAY (September 11, 1996)
  • K953888 — TELESCOPE 4MM, 2.7MM DIAM. WIDE ANGLE 0', 30', 70', 4MM, DIAM, 30' WORK, L 14CM, (October 7, 1995)

Other clearances for product code FFS

  • K072521 — COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH (November 20, 2007)
  • K061622 — PS SERIES (March 5, 2007)
  • K063309 — TRU-CABLE (January 12, 2007)
  • K061025 — ACCUTECH ENDOLITE PROBE (May 31, 2006)
  • K023633 — SOVIS OPTIQUE'S ENDOSCOPIC CABLE (December 31, 2002)
  • K001698 — MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159 (July 17, 2000)
  • K994084 — SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES (January 20, 2000)
  • K991323 — SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR (July 6, 1999)
  • K983714 — SOLARTEC SOURCE 270, MODEL # 90123 (December 23, 1998)
  • K982462 — FIBER OPTIC ENDOILLUMINATION PROBE (September 14, 1998)

FDA data resources