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510(k) K021290

VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE ACTIVATION AND PIP, MODEL 9100 by Vista Medical Technologies, Inc. — Product Code GCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2002
Date Received
April 23, 2002
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, General & Plastic Surgery
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Vista Medical Technologies, Inc.

  • 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)
  • 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)

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