Cleared Traditional

K951476 - E-PACK PROCEDURE KITS

K951476 is the FDA 510(k) clearance for E-PACK PROCEDURE KITS by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code MCY) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K951476 · Ethicon, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
May 1995
Decision
54d
Days
Class 2
Risk

K951476 is an FDA 510(k) clearance for the E-PACK PROCEDURE KITS. Classified as Wound Dressing Kit (product code MCY), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on May 23, 1995 after a review of 54 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5075 - 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: 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 Ethicon, Inc. devices

Submission Details

510(k) Number K951476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received March 30, 1995
Decision Date May 23, 1995
Days to Decision 54 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 115d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MCY Wound Dressing Kit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5075
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - MCY Wound Dressing Kit

Devices cleared under the same product code (MCY) and FDA review panel - the closest regulatory comparables to K951476.
DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM
K970721 · Johnson & Johnson Medical, Inc. · Mar 1997
CIRCULON SYSTEM STEP 2
K951021 · Convatec, A Division of E.R. Squibb & Sons · Jun 1995
CIRCULON SYSTEM STEP 1
K951022 · Convatec, A Division of E.R. Squibb & Sons · Jun 1995
DRESSING CHANGE TRAY-MODIFIED
K931932 · Medsurg Industries, Inc. · Aug 1993
TPN TRAY (STERILE)
K925021 · Customed, Inc. · Jun 1993
MEGA DRESSING CHANGE KIT
K910363 · Megadyne Medical Products, Inc. · Mar 1991