Cleared Traditional

K811961 - VISITEC NEEDLE RANGE (ORTHOPAEDIC) (FDA 510(k) Clearance)

K811961 · Visitec Co. · Orthopedic device
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Jul 1981
Decision
10d
Days
-
Risk

K811961 is an FDA 510(k) clearance for the VISITEC NEEDLE RANGE (ORTHOPAEDIC).

Submitted by Visitec Co. (Mchenry, US). The FDA issued a Cleared decision on July 20, 1981 after a review of 10 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.

View all Visitec Co. devices

Submission Details

510(k) Number K811961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1981
Decision Date July 20, 1981
Days to Decision 10 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 122d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -