VISTEK ELECTRONIC CONTROLLER— 510(k) K904682

Name: FDA 510(k) clearance K904682
Creator: U.S. Food and Drug Administration
Published: 1990-12-18

Substantially Equivalent

Vistek Corp.

FDA 510(k) clearance K904682 for VISTEK ELECTRONIC CONTROLLER, Substantially Equivalent on 1990-12-18. Applicant: Vistek Corp.. Device class: 1.

Clearance details

Applicant: Vistek Corp.
Product code: Code GEY
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1990-10-15
Decision date: 1990-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GEY

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K050519 — ADVANCED TURBO DRIVE SYSTEM2005-05-17
K020621 — ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS2002-03-28
K012738 — SYMPHONY GRAFT DELIVERY SYSTEM (GDS)2001-11-14
K972308 — MEDNEXT 1000 DRILL1997-08-20
K971941 — AQUA SPRAY1997-08-14

More clearances from Vistek Corp.

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K904681 — VLS 5300 300W XENON LIGHT SOURCE1990-12-18
K871034 — LCA 20001987-04-10
K860173 — VIS-2000 VIDEO SYSTEM1986-02-07
K843806 — VIS-1000 VIDEO SYSTEM1984-12-12

Adverse events under product code GEY

product code GEY

Malfunction: 7,488
Total: 7,488

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.