Cleared Traditional

K001023 - FREEDOM, MODEL 4660

K001023 · Johnson & Johnson Consumer Companies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K001023

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 115d · This submission: 176d
Pathway characteristics
Predicate-based equivalence.

SEJ Device Classification - Class 0,

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.

Regulatory Peers - SEJ Wound Dressings Containing Topical Analgesics

Devices cleared under the same product code (SEJ) and FDA review panel - the closest regulatory comparables to K001023.
AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025
K092086 · Amerx Health Care Corp. · Jul 2009
ALLWOUND
K053476 · At Squared, LLC · Jun 2006
REGENECARE WOUND GEL
K020540 · Mpm Medical., Inc. · Nov 2002
HEMO-STAT
K922636 · Mckinley-Ross Laboratories, Inc. · Nov 1992
MICRO-COLL COLLAGEN WOUND SPRAY
K912565 · Micro-Coll · Jun 1992
K001023 · FREEDOM, MODEL 4660
Download PDF FDA Summary Johnson & Johnson Con…