Cleared Traditional

VICKERS ERGOMATIC MICROS INSTR-FINE R OR L HANDED (K853181) - FDA 510(k) Clearance

Class I Neurology device.

K853181 · Keeler Instruments, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1985
Decision
90d
Days
Class 1
Risk

K853181 is an FDA 510(k) clearance for the VICKERS ERGOMATIC MICROS INSTR-FINE R OR L HANDED. 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 October 28, 1985 after a review of 90 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.

View all Keeler Instruments, Inc. devices

Submission Details

510(k) Number K853181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1985
Decision Date October 28, 1985
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
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.