Cleared Traditional

UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE (K860168) - FDA 510(k) Clearance

K860168 · Universal Medical Instrument Corp. · General & Plastic Surgery device
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Feb 1986
Decision
33d
Days
-
Risk

K860168 is an FDA 510(k) clearance for the UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE.

Submitted by Universal Medical Instrument Corp. (Ballston Spa, US). The FDA issued a Cleared decision on February 19, 1986 after a review of 33 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 Universal Medical Instrument Corp. devices

Submission Details

510(k) Number K860168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1986
Decision Date February 19, 1986
Days to Decision 33 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
82d faster than avg
Panel avg: 115d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -