Cleared Traditional

K854068 - EXTERNAL MECHANICAL FASTENER (FDA 510(k) Clearance)

K854068 · Wells Johnson Co. · General & Plastic Surgery device
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Nov 1985
Decision
49d
Days
-
Risk

K854068 is an FDA 510(k) clearance for the EXTERNAL MECHANICAL FASTENER.

Submitted by Wells Johnson Co. (Tucson, US). The FDA issued a Cleared decision on November 22, 1985 after a review of 49 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 Wells Johnson Co. devices

Submission Details

510(k) Number K854068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1985
Decision Date November 22, 1985
Days to Decision 49 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
65d faster than avg
Panel avg: 114d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -