Cleared Traditional

K851764 - 13-340,13-350,13-360 LIGATURE SCISSORE SPENCER/LIT (FDA 510(k) Clearance)

K851764 · Artiberia · General & Plastic Surgery device
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Jun 1985
Decision
56d
Days
-
Risk

K851764 is an FDA 510(k) clearance for the 13-340,13-350,13-360 LIGATURE SCISSORE SPENCER/LIT.

Submitted by Artiberia (San Antonio, US). The FDA issued a Cleared decision on June 20, 1985 after a review of 56 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.

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Submission Details

510(k) Number K851764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1985
Decision Date June 20, 1985
Days to Decision 56 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
58d faster than avg
Panel avg: 114d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -