Cleared Traditional

K003396 - BURN JEL PLUS

K003396 · Water-Jel Technologies, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
71d
Days
-
Risk

K003396 is an FDA 510(k) clearance for the BURN JEL PLUS. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Water-Jel Technologies, LLC (Carlstadt, US). The FDA issued a Cleared decision on January 11, 2001 after a review of 71 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K003396

510(k) Number K003396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2000
Decision Date January 11, 2001
Days to Decision 71 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
44d faster than avg
Panel avg: 115d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

MGQ Device Classification - Class 0,

Product Code MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class -

Regulatory Peers - MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

All 144
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K003396.
ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101
K011994 · Acrymed, Inc. · Nov 2001
AMBU GEL, HYDROGEL BURN DRESSING
K010583 · Ambu, Inc. · May 2001
DIAMOND ALOE VERA, STERILE
K002666 · Medi-Tech Intl. Corp. · Feb 2001
GLUCANPRO CREAM
K002077 · Brennen Medical, Inc. · Oct 2000
BETA GLUCAN GEL (MACROPRO GEL)
K002078 · Brennen Medical, Inc. · Oct 2000
FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN
K002129 · Ferris Mfg. Corp. · Aug 2000
K003396 · BURN JEL PLUS
Download PDF FDA Summary Water-Jel Technologie…