Cleared Traditional

K002129 - FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN

K002129 · Ferris Mfg. Corp. · General & Plastic Surgery device
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Aug 2000
Decision
42d
Days
-
Risk

K002129 is an FDA 510(k) clearance for the FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Ferris Mfg. Corp. (Burr Ridge, US). The FDA issued a Cleared decision on August 25, 2000 after a review of 42 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 Ferris Mfg. Corp. devices

FDA 510(k) Submission Details - K002129

510(k) Number K002129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2000
Decision Date August 25, 2000
Days to Decision 42 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
73d faster than avg
Panel avg: 115d · This submission: 42d
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 89
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K002129.
AMBU GEL, HYDROGEL BURN DRESSING
K010583 · Ambu, Inc. · May 2001
GLUCANPRO CREAM
K002077 · Brennen Medical, Inc. · Oct 2000
BETA GLUCAN GEL (MACROPRO GEL)
K002078 · Brennen Medical, Inc. · Oct 2000
MACROPRO GEL
K000518 · Brennen Medical, Inc. · May 2000
GLUCANPRO
K000519 · Brennen Medical, Inc. · May 2000
MEDLINE TENDER WET WOUND DRESSING
K991755 · Medline Industries, Inc. · Apr 2000