Cleared Traditional

K904682 - VISTEK ELECTRONIC CONTROLLER

K904682 is an FDA 510(k) clearance for VISTEK ELECTRONIC CONTROLLER, manufactured by Vistek Corp.. The device is a Class 1 General & Plastic Surgery device with product code GEY cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K904682 · Vistek Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1990
Decision
64d
Days
Class 1
Risk

K904682 is an FDA 510(k) clearance for the VISTEK ELECTRONIC CONTROLLER. Classified as Motor, Surgical Instrument, Ac-powered (product code GEY), Class I - General Controls.

Submitted by Vistek Corp. (Goleta, US). The FDA issued a Cleared decision on December 18, 1990 after a review of 64 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vistek Corp. devices

FDA 510(k) Submission Details - K904682

510(k) Number K904682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1990
Decision Date December 18, 1990
Days to Decision 64 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 115d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

GEY Device Classification - Class 1, General Controls

Product Code GEY Motor, Surgical Instrument, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GEY Motor, Surgical Instrument, Ac-powered

All 26
Devices cleared under the same product code (GEY) and FDA review panel - the closest regulatory comparables to K904682.
AUTO LUBE SYSTEM
K940535 · The Anspach Effort, Inc. · Mar 1994
CUTO(TM) TISSUE MORCELLATION SYSTEM
K932700 · Linvatec Corp. · Oct 1993
AESCULAP SURGICAL ACCESSORIES
K913262 · Aesculap, Inc. · Dec 1991
MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS
K900033 · Micro-Aire Surgical Instruments, Inc. · Feb 1990
THE DEXTRA PRECISION POWER UNIT
K853778 · Storz Instrument Co. · Nov 1985
DRILLING TEMPLATE
K853761 · Orthopedic Systems, Inc. · Oct 1985