Cleared Traditional

K853161 - THE VICKERS STANDARD MICROSURGERY SET

K853161 is an FDA 510(k) clearance for THE VICKERS STANDARD MICROSURGERY SET, manufactured by Keeler Instruments, Inc.. The device is a Class 1 Neurology device with 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

FDA 510(k) Submission Details - K853161

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.

GZX Device Classification - Class 1, General Controls

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 9
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