Cleared Traditional

K844147 - WIRE TWISTERS (FDA 510(k) Clearance)

K844147 · Med-Tool, Inc. · General & Plastic Surgery device
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Nov 1984
Decision
28d
Days
-
Risk

K844147 is an FDA 510(k) clearance for the WIRE TWISTERS.

Submitted by Med-Tool, Inc. (St. Louis, US). The FDA issued a Cleared decision on November 20, 1984 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery 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.

View all Med-Tool, Inc. devices

Submission Details

510(k) Number K844147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1984
Decision Date November 20, 1984
Days to Decision 28 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 114d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -