Cleared Traditional

K952276 - MPM HYDROGEL DRESSING

K952276 · Mpm Medical., Inc. · General & Plastic Surgery device
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Jun 1995
Decision
46d
Days
-
Risk

K952276 is an FDA 510(k) clearance for the MPM HYDROGEL DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Mpm Medical., Inc. (Fort Worth, US). The FDA issued a Cleared decision on June 30, 1995 after a review of 46 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 - K952276

510(k) Number K952276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1995
Decision Date June 30, 1995
Days to Decision 46 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
69d faster than avg
Panel avg: 115d · This submission: 46d
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 K952276.
MULTIDEX GEL
K952774 · Lange Medical Products, Inc. · Jul 1995
A GEL WOUND DRESSING
K951862 · Polymedica Industries, Inc. · Jul 1995
STERICARE WOUND CARE GEL
K951861 · Acacia Laboratories, Inc. · Jul 1995
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
K952276 · MPM HYDROGEL DRESSING
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