Cleared Traditional

K853179 - VICKERS ERGOMATIC MICROSUR INSTRU-UNIV R O L HAND (FDA 510(k) Clearance)

Class I Neurology device.

K853179 · Keeler Instruments, Inc. · Neurology device
Nov 1985
Decision
100d
Days
Class 1
Risk

K853179 is an FDA 510(k) clearance for the VICKERS ERGOMATIC MICROSUR INSTRU-UNIV R O L HAND. Classified as Instrument, Microsurgical (product code GZX), Class I - General Controls.

Submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on November 7, 1985 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4525 - the FDA neurology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K853179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1985
Decision Date November 07, 1985
Days to Decision 100 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 162d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GZX Instrument, Microsurgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.4525
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.