Cleared Traditional

K862331 - FUJITSU MALLEABLE - TIP BRAIN SPATULA (FDA 510(k) Clearance)

Class I Neurology device.

K862331 · Downs Surgical , Ltd. · Neurology device
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Jul 1986
Decision
12d
Days
Class 1
Risk

K862331 is an FDA 510(k) clearance for the FUJITSU MALLEABLE - TIP BRAIN SPATULA. Classified as Instrument, Surgical, Non-powered (product code HAO), Class I - General Controls.

Submitted by Downs Surgical , Ltd. (Wilmington, US). The FDA issued a Cleared decision on July 1, 1986 after a review of 12 days - a notably fast clearance cycle.

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: 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

Submission Details

510(k) Number K862331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1986
Decision Date July 01, 1986
Days to Decision 12 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
136d faster than avg
Panel avg: 148d · This submission: 12d
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.