Cleared Traditional

K841388 - ACUFEX SHOULDER HOLDER (FDA 510(k) Clearance)

Class I Neurology device.

K841388 · Acufex Microsurgical, Inc. · Neurology device
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May 1984
Decision
43d
Days
Class 1
Risk

K841388 is an FDA 510(k) clearance for the ACUFEX SHOULDER HOLDER. Classified as Apparatus, Traction, Non-powered (product code HST), Class I - General Controls.

Submitted by Acufex Microsurgical, Inc. (Walker, US). The FDA issued a Cleared decision on May 16, 1984 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.5850 - 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 Acufex Microsurgical, Inc. devices

Submission Details

510(k) Number K841388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1984
Decision Date May 16, 1984
Days to Decision 43 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 148d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HST Apparatus, Traction, Non-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.5850
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.