Cleared Traditional

K-MESH (K843829) - FDA 510(k) Clearance

K843829 · Katecho, Inc. · General & Plastic Surgery device
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Jun 1985
Decision
247d
Days
-
Risk

K843829 is an FDA 510(k) clearance for the K-MESH.

Submitted by Katecho, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 5, 1985 after a review of 247 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Katecho, Inc. devices

Submission Details

510(k) Number K843829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1984
Decision Date June 05, 1985
Days to Decision 247 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
132d slower than avg
Panel avg: 115d · This submission: 247d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -