Cleared Traditional

K940973 - MULLAN GANGLION MICROCOMPRESSION SET (FDA 510(k) Clearance)

Class I Neurology device.

K940973 · Cook, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
575d
Days
Class 1
Risk

K940973 is an FDA 510(k) clearance for the MULLAN GANGLION MICROCOMPRESSION SET. Classified as Instrument, Surgical, Non-powered (product code HAO), Class I - General Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on September 29, 1995 after a review of 575 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4535 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Cook, Inc. devices

Submission Details

510(k) Number K940973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1994
Decision Date September 29, 1995
Days to Decision 575 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
427d slower than avg
Panel avg: 148d · This submission: 575d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HAO Instrument, Surgical, Non-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.4535
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.