Cleared Traditional

K952938 - AQUAFLO BTP HYDROGEL WOUND DRESSING

K952938 · Sherwood Medical Co. · General & Plastic Surgery device
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Dec 1995
Decision
165d
Days
-
Risk

K952938 is an FDA 510(k) clearance for the AQUAFLO BTP HYDROGEL WOUND DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on December 8, 1995 after a review of 165 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 Sherwood Medical Co. devices

FDA 510(k) Submission Details - K952938

510(k) Number K952938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1995
Decision Date December 08, 1995
Days to Decision 165 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
50d slower than avg
Panel avg: 115d · This submission: 165d
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 89
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K952938.
QUEGEL HYDROPHILIC WOUND DRESSING
K955400 · Questor Pharma, Inc. · Feb 1996
IAMIN GEL WOUND DRESSING
K953853 · Procyte Corp. · Feb 1996
TECNOL HYDROGEL WOUND DRESSING
K955575 · Tecnol Medical Products, Inc. · Jan 1996
DERMAGRAN (ZINC SALINE) HYDROGEL WOUND DRESSING
K954664 · Derma Sciences, Inc. · Nov 1995
DERMAGRAN WENT DRESSING (DEXTROSE-SALINE)
K954741 · Derma Sciences, Inc. · Nov 1995
DEROYAL WOUND CARE MULTIDEX GEL WOUND DRESSING
K952775 · Deroyal Industries, Inc. · Oct 1995