Cleared Traditional

K873934 - RANGE OF CROCODILE ACTION INSTRUMENTS

K873934 is an FDA 510(k) clearance for RANGE OF CROCODILE ACTION INSTRUMENTS, manufactured by Downs Surgical , Ltd.. The device is a Class 1 Neurology device with product code GZX cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K873934 · Downs Surgical , Ltd. · Neurology device
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Dec 1987
Decision
83d
Days
Class 1
Risk

K873934 is an FDA 510(k) clearance for the RANGE OF CROCODILE ACTION INSTRUMENTS. Classified as Instrument, Microsurgical (product code GZX), Class I - General Controls.

Submitted by Downs Surgical , Ltd. (Sheffield S9 4wj, GB). The FDA issued a Cleared decision on December 17, 1987 after a review of 83 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 Downs Surgical , Ltd. devices

FDA 510(k) Submission Details - K873934

510(k) Number K873934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1987
Decision Date December 17, 1987
Days to Decision 83 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
65d faster than avg
Panel avg: 148d · This submission: 83d
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 K873934.
MICROSURGICAL KERATOME
K890216 · Kinetic Medical Products · Feb 1989
RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM
K873933 · Downs Surgical , Ltd. · Dec 1987
MICRA MICROSURGICAL INSTRUMENTS
K862971 · Cordis Corp. · Aug 1986
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