Cleared Traditional

K933085 - GOODMAN BANDAGE (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K933085 · Megadyne Medical Products, Inc. · General & Plastic Surgery device
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Dec 1993
Decision
183d
Days
Class 1
Risk

K933085 is an FDA 510(k) clearance for the GOODMAN BANDAGE. Classified as Bag, Intestine (product code KGY), Class I - General Controls.

Submitted by Megadyne Medical Products, Inc. (Draper, US). The FDA issued a Cleared decision on December 23, 1993 after a review of 183 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4100 - the FDA general and plastic surgery device framework. 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 Megadyne Medical Products, Inc. devices

Submission Details

510(k) Number K933085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1993
Decision Date December 23, 1993
Days to Decision 183 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 114d · This submission: 183d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGY Bag, Intestine
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.