Cleared Traditional

FREEDOM, MODEL 4660 (K001023) - FDA 510(k) Clearance

K001023 · Johnson & Johnson Consumer Companies, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Sep 2000
Decision
176d
Days
-
Risk

K001023 is an FDA 510(k) clearance for the FREEDOM, MODEL 4660. Classified as Wound Dressings Containing Topical Analgesics (product code SEJ).

Submitted by Johnson & Johnson Consumer Companies, Inc. (Skillman, US). The FDA issued a Cleared decision on September 22, 2000 after a review of 176 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.

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Submission Details

510(k) Number K001023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2000
Decision Date September 22, 2000
Days to Decision 176 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 115d · This submission: 176d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code SEJ Wound Dressings Containing Topical Analgesics
Device Class -
Definition A Solid Wound Dressing Containing Topical Analgesics Is Used To Cover And Protect A Wound, To Absorb Exudate, To Maintain Appropriate Moisture Balance Within The Wound, And To Reduce Pain. A Wound Dressing Formulated As A Gel, Cream Or Ointment Containing Topical Analgesics Is Used To Maintain Appropriate Moisture Balance Within The Wound And To Reduce Pain.