Cleared Traditional

K761141 - ARTERIAL GRAFT SIZERS (FDA 510(k) Clearance)

K761141 · Pilling Co. · General & Plastic Surgery device
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Jan 1977
Decision
41d
Days
-
Risk

K761141 is an FDA 510(k) clearance for the ARTERIAL GRAFT SIZERS.

Submitted by Pilling Co. (Mchenry, US). The FDA issued a Cleared decision on January 6, 1977 after a review of 41 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 Pilling Co. devices

Submission Details

510(k) Number K761141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1976
Decision Date January 06, 1977
Days to Decision 41 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
73d faster than avg
Panel avg: 114d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -