Cleared Traditional

K933085 - GOODMAN BANDAGE

K933085 is an FDA 510(k) clearance for GOODMAN BANDAGE, manufactured by Megadyne Medical Products, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGY cleared through the Traditional 510(k) pathway after a 183-day FDA review.

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

FDA 510(k) Submission Details - K933085

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 115d · This submission: 183d
Pathway characteristics
Predicate-based equivalence.

KGY Device Classification - Class 1, General Controls

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.

Regulatory Peers - KGY Bag, Intestine

Devices cleared under the same product code (KGY) and FDA review panel - the closest regulatory comparables to K933085.
TROCAR CATHETER
K913678 · Medovations, Inc. · Dec 1991
SURGICAL TISSUE POUCH
K910914 · Cook Urological, Inc. · Mar 1991
ISOLATION BAG 3M
K832318 · 3M Company · Oct 1983
BAND-AID BRAND TRICOT MESH BANDAGES
K801823 · Johnson & Johnson Professionals, Inc. · Aug 1980
BAND-AID BRAND FLEXIBLE FABRIC BANDAGE
K801824 · Johnson & Johnson Professionals, Inc. · Aug 1980