Cleared Traditional

K853161 - THE VICKERS STANDARD MICROSURGERY SET

K853161 is the FDA 510(k) clearance for THE VICKERS STANDARD MICROSURGERY SET by Keeler Instruments, Inc.. It is a Class 1 Neurology device (product code GZX) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K853161 · Keeler Instruments, Inc. · Neurology device
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Nov 1985
Decision
100d
Days
Class 1
Risk

K853161 is an FDA 510(k) clearance for the THE VICKERS STANDARD MICROSURGERY SET. 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.

View all Keeler Instruments, Inc. devices

Submission Details

510(k) Number K853161 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 -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 148d · 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.

Regulatory Peers - GZX Instrument, Microsurgical

All 7
Devices cleared under the same product code (GZX) and FDA review panel - the closest regulatory comparables to K853161.
RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM
K873933 · Downs Surgical , Ltd. · Dec 1987
RANGE OF CROCODILE ACTION INSTRUMENTS
K873934 · Downs Surgical , Ltd. · Dec 1987
MICRA MICROSURGICAL INSTRUMENTS
K862971 · Cordis Corp. · Aug 1986
VICKERS ERGOMATIC MICROSUR INSTRU-UNIV R O L HAND
K853179 · Keeler Instruments, Inc. · Nov 1985
VICKERS ERGOMATIC MICROS INSTR-LONG R OR L HANDED
K853180 · Keeler Instruments, Inc. · Oct 1985
VICKERS ERGOMATIC MICROS INSTR-FINE R OR L HANDED
K853181 · Keeler Instruments, Inc. · Oct 1985