Cleared Traditional

K945005 - PANOPLEX HYDROGEL WOUND DRESSING

K945005 · Sage Pharmaceuticals, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
162d
Days
-
Risk

K945005 is an FDA 510(k) clearance for the PANOPLEX HYDROGEL WOUND DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Sage Pharmaceuticals, Inc. (Shreveport, US). The FDA issued a Cleared decision on March 24, 1995 after a review of 162 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.

View all Sage Pharmaceuticals, Inc. devices

FDA 510(k) Submission Details - K945005

510(k) Number K945005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1994
Decision Date March 24, 1995
Days to Decision 162 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 115d · This submission: 162d
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 47
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K945005.
DERMAGRAN WENT DRESSING (DEXTROSE-SALINE)
K954741 · Derma Sciences, Inc. · Nov 1995
DEROYAL WOUND CARE MULTIDEX GEL WOUND DRESSING
K952775 · Deroyal Industries, Inc. · Oct 1995
A GEL WOUND DRESSING
K951862 · Polymedica Industries, Inc. · Jul 1995
CURAFIL WOUND GEL DRESSING
K943073 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jul 1994
BIOLEX IMPREGNATED WOUND DRESSING
K935096 · C.R. Bard, Inc. · Feb 1994
DUODERM IMPROVED CGF CONTROL GEL FORMULA DRESSING
K932101 · Convatec, A Division of E.R. Squibb & Sons · Dec 1993