TELESCOPE 4MM, 2.7MM DIAM. WIDE ANGLE 0', 30', 70', 4MM, DIAM, 30' WORK, L 14CM, AUTOCLAVABLE— 510(k) K953888

Name: FDA 510(k) clearance K953888
Creator: U.S. Food and Drug Administration
Published: 1995-10-07

Substantially Equivalent

Vista Medical Technologies, Inc.

FDA 510(k) clearance K953888 for TELESCOPE 4MM, 2.7MM DIAM. WIDE ANGLE 0', 30', 70', 4MM, DIAM, 30' WORK, L 14CM, AUTOCLAVABLE, Substantially Equivalent on 1995-10-07. Applicant: Vista Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Vista Medical Technologies, Inc.
Product code: Code EOB
Device class: Class 2
Regulation: 21 CFR 874.4760
Advisory panel: Ear, Nose, Throat
Date received: 1995-08-17
Decision date: 1995-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oceanside, CA, US

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K021290 — VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE ACTIVATION AND PIP, MODEL 91002002-06-28
K020301 — MODIFICATION TO VISTA STEREOSCOPE SYSTEM2002-02-12
K991303 — VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE1999-07-12
K990635 — VISTA STEREOSCOPE SYSTEM1999-05-19
K973436 — VISTA HEAD MOUNTED DISPLAY1997-12-09

Adverse events under product code EOB

product code EOB

Malfunction: 6,143
Total: 6,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.