Cleared Traditional

MORWEL CANNULA (K831520) - FDA 510(k) Clearance

K831520 · Morwel Corp. · General & Plastic Surgery device
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Jun 1983
Decision
39d
Days
-
Risk

K831520 is an FDA 510(k) clearance for the MORWEL CANNULA.

Submitted by Morwel Corp. (Mchenry, US). The FDA issued a Cleared decision on June 20, 1983 after a review of 39 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 Morwel Corp. devices

Submission Details

510(k) Number K831520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1983
Decision Date June 20, 1983
Days to Decision 39 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
76d faster than avg
Panel avg: 115d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -