Cleared Traditional

K941339 - STERILE WOUND HYDROGEL DRESSING

K941339 · Renaissance Pharmaceutical, Inc. · General & Plastic Surgery device
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Jun 1994
Decision
81d
Days
-
Risk

K941339 is an FDA 510(k) clearance for the STERILE WOUND HYDROGEL DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Renaissance Pharmaceutical, Inc. (Dana Point, US). The FDA issued a Cleared decision on June 10, 1994 after a review of 81 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 - K941339

510(k) Number K941339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1994
Decision Date June 10, 1994
Days to Decision 81 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
34d faster than avg
Panel avg: 115d · This submission: 81d
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 K941339.
EUTRA GEL FOR WOUND DRESSING
K932291 · Swiss American Products, Inc. · Jul 1994
M-K HYDROGEL DRESSING
K940409 · Mason-Keller Corp. · Jul 1994
MPM HYDROGEL
K942798 · Mpm Medical., Inc. · Jul 1994
HYDRO-M(TM) WOUND GEL
K940814 · Kingston Technologies, Inc. · May 1994
FLOWGEL(R) TOPICAL WOUND DRESSING
K926353 · Mediventures, Inc. · Feb 1994
BIOLEX IMPREGNATED WOUND DRESSING
K935096 · C.R. Bard, Inc. · Feb 1994
K941339 · STERILE WOUND HYDROGEL DRESSING
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