Cleared Traditional

K862971 - MICRA MICROSURGICAL INSTRUMENTS

K862971 is an FDA 510(k) clearance for MICRA MICROSURGICAL INSTRUMENTS, manufactured by Cordis Corp.. The device is a Class 1 Neurology device with product code GZX cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K862971 · Cordis Corp. · Neurology device
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Aug 1986
Decision
19d
Days
Class 1
Risk

K862971 is an FDA 510(k) clearance for the MICRA MICROSURGICAL INSTRUMENTS. Classified as Instrument, Microsurgical (product code GZX), Class I - General Controls.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on August 25, 1986 after a review of 19 days - a notably fast clearance cycle.

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: 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 Cordis Corp. devices

FDA 510(k) Submission Details - K862971

510(k) Number K862971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1986
Decision Date August 25, 1986
Days to Decision 19 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
129d faster than avg
Panel avg: 148d · This submission: 19d
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 8
Devices cleared under the same product code (GZX) and FDA review panel - the closest regulatory comparables to K862971.
MICROSURGICAL KERATOME
K890216 · Kinetic Medical Products · Feb 1989
RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM
K873933 · Downs Surgical , Ltd. · Dec 1987
RANGE OF CROCODILE ACTION INSTRUMENTS
K873934 · Downs Surgical , Ltd. · Dec 1987
THE VICKERS STANDARD MICROSURGERY SET
K853161 · Keeler Instruments, Inc. · Nov 1985
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