Cleared Traditional

K945005 - PANOPLEX HYDROGEL WOUND DRESSING

K945005 · Sage Pharmaceuticals, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 138
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K945005.
MPM HYDROGEL DRESSING
K950934 · Richard Hamer Assoc., Inc. · May 1995
HYDROGEL DRESSING
K945217 · O.R. Resources, Inc. · May 1995
CARRASYN HYDROGEL WOUND DRESSING, FDG PADS, CARRAGAUZE PADS, STRIPS
K951417 · Carrington Laboratories, Inc. · May 1995
BIAFINE
K943910 · Laboratoire Medix · Feb 1995
DERMASSIST(TM) HYDROGEL SATURATED GAUZE DRESSING
K946030 · Wilshire Medical Products · Feb 1995
DERMASSIST(TM) HYDROGEL SATURATEED NON WOVEN DRESSING
K946031 · Wilshire Medical Products · Feb 1995
K945005 · PANOPLEX HYDROGEL WOUND DRESSING
Download PDF FDA Summary Sage Pharmaceuticals,…