Cleared Traditional

HUCKSTEPS STAPLES (K841125) - FDA 510(k) Clearance

K841125 · Downs Surgical , Ltd. · Orthopedic device
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May 1984
Decision
69d
Days
-
Risk

K841125 is an FDA 510(k) clearance for the HUCKSTEPS STAPLES.

Submitted by Downs Surgical , Ltd. (Walker, US). The FDA issued a Cleared decision on May 23, 1984 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel. 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.

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Submission Details

510(k) Number K841125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1984
Decision Date May 23, 1984
Days to Decision 69 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 122d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -