Cleared Traditional

K800274 - ACUFEX PROBES (FDA 510(k) Clearance)

Class I Orthopedic device.

K800274 · Acufex Microsurgical, Inc. · Orthopedic device
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Feb 1980
Decision
12d
Days
Class 1
Risk

K800274 is an FDA 510(k) clearance for the ACUFEX PROBES. Classified as Probe (product code HXB), Class I - General Controls.

Submitted by Acufex Microsurgical, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 19, 1980 after a review of 12 days - a notably fast clearance cycle.

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: 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 K800274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1980
Decision Date February 19, 1980
Days to Decision 12 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 122d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HXB Probe
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.