Cleared Traditional

K930560 - MPM HYDROGEL SATURATED DRESSING

K930560 · Mpm Medical., Inc. · General & Plastic Surgery device
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Jul 1993
Decision
155d
Days
-
Risk

K930560 is an FDA 510(k) clearance for the MPM HYDROGEL SATURATED 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 July 8, 1993 after a review of 155 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 - K930560

510(k) Number K930560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1993
Decision Date July 08, 1993
Days to Decision 155 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
40d slower than avg
Panel avg: 115d · This submission: 155d
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 K930560.
DAMOR CREAM SATURATED DRESSING
K934267 · Damor America, Inc. · Dec 1993
SOLOSITE DERMAL WOUND GEL
K932263 · Smith & Nephew United, Inc. · Oct 1993
SWEEN WOUND CARE-COLLAGEN WOUND DRESSING
K926389 · Sween Corp. · Jul 1993
KOLD WRAP STERILE BURN DRESSING
K920554 · Kold Products · Feb 1993
ROYL-DERM WOUND HYDROGEL
K922815 · Renaissance Medical, Inc. · Oct 1992
CURASOL(TM) WOUND DRESSING
K921810 · Healthsouth Medical Center · Jul 1992
K930560 · MPM HYDROGEL SATURATED DRESSING
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