Cleared Traditional

K951862 - A GEL WOUND DRESSING

K951862 · Polymedica Industries, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
82d
Days
-
Risk

K951862 is an FDA 510(k) clearance for the A GEL WOUND DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Polymedica Industries, Inc. (Golden,, US). The FDA issued a Cleared decision on July 12, 1995 after a review of 82 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 - K951862

510(k) Number K951862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1995
Decision Date July 12, 1995
Days to Decision 82 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
33d faster than avg
Panel avg: 115d · This submission: 82d
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 137
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K951862.
BURNSHIELD TRAUMA DRESSING
K952247 · Golightly International Corp. · Jul 1995
STERIGAUZE GEL DRESSING
K952419 · Acacia Laboratories, Inc. · Jul 1995
MULTIDEX GEL
K952774 · Lange Medical Products, Inc. · Jul 1995
STERICARE WOUND CARE GEL
K951861 · Acacia Laboratories, Inc. · Jul 1995
MPM HYDROGEL DRESSING
K952276 · Mpm Medical., Inc. · Jun 1995
MPM HYDROGEL DRESSING
K950934 · Richard Hamer Assoc., Inc. · May 1995
K951862 · A GEL WOUND DRESSING
Download PDF FDA Summary Polymedica Industries…