Cleared Traditional

K000518 - MACROPRO GEL

K000518 · Brennen Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
75d
Days
-
Risk

K000518 is an FDA 510(k) clearance for the MACROPRO GEL. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Brennen Medical, Inc. (St. Paul, US). The FDA issued a Cleared decision on May 1, 2000 after a review of 75 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.

View all Brennen Medical, Inc. devices

FDA 510(k) Submission Details - K000518

510(k) Number K000518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2000
Decision Date May 01, 2000
Days to Decision 75 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
40d faster than avg
Panel avg: 115d · This submission: 75d
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 90
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K000518.
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
GLUCANPRO
K000519 · Brennen Medical, Inc. · May 2000
MEDLINE TENDER WET WOUND DRESSING
K991755 · Medline Industries, Inc. · Apr 2000
MPM REGENECARE WOUND GEL
K992074 · Mpm Medical., Inc. · Dec 1999