Cleared Traditional

K920621 - ACUFEX PASSING PINS AND SURGICAL WIRE (FDA 510(k) Clearance)

Class I Orthopedic device.

K920621 · Acufex Microsurgical, Inc. · Orthopedic device
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May 1993
Decision
449d
Days
Class 1
Risk

K920621 is an FDA 510(k) clearance for the ACUFEX PASSING PINS AND SURGICAL WIRE. Classified as Passer (product code HWQ), Class I - General Controls.

Submitted by Acufex Microsurgical, Inc. (Great Neck, US). The FDA issued a Cleared decision on May 5, 1993 after a review of 449 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - the FDA orthopedic device regulatory 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 Orthopedic submissions.

View all Acufex Microsurgical, Inc. devices

Submission Details

510(k) Number K920621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1992
Decision Date May 05, 1993
Days to Decision 449 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
327d slower than avg
Panel avg: 122d · This submission: 449d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HWQ Passer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
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.