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510(k) K020301

MODIFICATION TO VISTA STEREOSCOPE SYSTEM by Vista Medical Technologies, Inc. — Product Code FET

K020301 is an FDA 510(k) premarket notification submitted by Vista Medical Technologies, Inc. for the device "MODIFICATION TO VISTA STEREOSCOPE SYSTEM". The FDA issued a decision of Substantially Equivalent on February 12, 2002. The device falls under product code FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology), 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
February 12, 2002
Date Received
January 29, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To allow for visualization of body cavities through an endoscope by projecting images to a monitor.

Other clearances by Vista Medical Technologies, Inc.

  • K021290 — VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE AC (June 28, 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)
  • K970217 — VISTA ILLUMINATION SYSTEM (April 2, 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 FET

  • K262079 — 4K Camera Head OLYMPUS CH-S700-08-LB (September 10, 2026)
  • K261880 — FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW (July 2, 2026)
  • K261260 — HD Camera Head OLYMPUS CH-S200-08-LB (June 24, 2026)
  • K251734 — ProVee Video Processing Unit (PV-003) (September 24, 2025)
  • K250462 — UL UHD-Clear View 4K Camera System (UL-3Chip 4K) (August 11, 2025)
  • K250204 — Endoscopic Camera System (July 1, 2025)
  • K243260 — FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R (April 11, 2025)
  • K242067 — VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGH (April 2, 2025)
  • K243321 — Endoscopic Video Image Processor (RP-IPD-V1000F) (February 7, 2025)
  • K241532 — Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) (October 22, 2024)

FDA data resources