Cleared Traditional

K002666 - DIAMOND ALOE VERA, STERILE

K002666 · Medi-Tech Intl. Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
186d
Days
-
Risk

K002666 is an FDA 510(k) clearance for the DIAMOND ALOE VERA, STERILE. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Medi-Tech Intl. Corp. (Brooklyn, US). The FDA issued a Cleared decision on February 27, 2001 after a review of 186 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 - K002666

510(k) Number K002666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2000
Decision Date February 27, 2001
Days to Decision 186 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
71d slower than avg
Panel avg: 115d · This submission: 186d
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 K002666.
L.A.M. IPM WOUND GEL
K020325 · L.A.M. Pharmaceutical, Corp. · Apr 2002
ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101
K011994 · Acrymed, Inc. · Nov 2001
AMBU GEL, HYDROGEL BURN DRESSING
K010583 · Ambu, Inc. · May 2001
BURN JEL PLUS
K003396 · Water-Jel Technologies, LLC · Jan 2001
GLUCANPRO CREAM
K002077 · Brennen Medical, Inc. · Oct 2000
BETA GLUCAN GEL (MACROPRO GEL)
K002078 · Brennen Medical, Inc. · Oct 2000
K002666 · DIAMOND ALOE VERA, STERILE
Download PDF Medi-Tech Intl. Corp.