Cleared Traditional

K811960 - VISITEC NEDDLE TANGE (SURGERY) (FDA 510(k) Clearance)

K811960 · Visitec Co. · General & Plastic Surgery device
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Aug 1981
Decision
28d
Days
-
Risk

K811960 is an FDA 510(k) clearance for the VISITEC NEDDLE TANGE (SURGERY).

Submitted by Visitec Co. (Mchenry, US). The FDA issued a Cleared decision on August 7, 1981 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 Visitec Co. devices

Submission Details

510(k) Number K811960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1981
Decision Date August 07, 1981
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 -