Cleared Traditional

K782154 - COLOSTOMY DEVICE, MACLET MAGNETIC (FDA 510(k) Clearance)

K782154 · Maclet Medical Devices, Inc. · General & Plastic Surgery device
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Jun 1979
Decision
181d
Days
-
Risk

K782154 is an FDA 510(k) clearance for the COLOSTOMY DEVICE, MACLET MAGNETIC.

Submitted by Maclet Medical Devices, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 21, 1979 after a review of 181 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 Maclet Medical Devices, Inc. devices

Submission Details

510(k) Number K782154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1978
Decision Date June 21, 1979
Days to Decision 181 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
67d slower than avg
Panel avg: 114d · This submission: 181d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -