Cleared Traditional

K952945 - AQUAFLO HYDROGEL WOUND DRESSING & PACKER (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K952945 · Sherwood Medical Co. · General & Plastic Surgery device
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Aug 1995
Decision
58d
Days
Class 1
Risk

K952945 is an FDA 510(k) clearance for the AQUAFLO HYDROGEL WOUND DRESSING & PACKER. Classified as Dressing, Wound, Hydrogel Without Drug And/or Biologic (product code NAE), Class I - General Controls.

Submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on August 23, 1995 after a review of 58 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4022 - the FDA general and plastic surgery device framework. 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.

View all Sherwood Medical Co. devices

Submission Details

510(k) Number K952945 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 26, 1995
Decision Date August 23, 1995
Days to Decision 58 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 114d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NAE Dressing, Wound, Hydrogel Without Drug And/or Biologic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4022
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.