Cleared Traditional

K862689 - 2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP (FDA 510(k) Clearance)

Class I Orthopedic device.

K862689 · W.L. Gore & Associates, Inc. · Orthopedic device
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Sep 1986
Decision
49d
Days
Class 1
Risk

K862689 is an FDA 510(k) clearance for the 2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP. Classified as Screwdriver (product code HXX), Class I - General Controls.

Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on September 2, 1986 after a review of 49 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 W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K862689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1986
Decision Date September 02, 1986
Days to Decision 49 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 122d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HXX Screwdriver
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.