Cleared Traditional

KENDALL HYDROPHILIC POWDER WOUND DRESSING (K970266) - FDA 510(k) Clearance

K970266 · Kendall Healthcare Products Co. Div.Of Tyco Health · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
90d
Days
-
Risk

K970266 is an FDA 510(k) clearance for the KENDALL HYDROPHILIC POWDER WOUND DRESSING. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on April 23, 1997 after a review of 90 days - within the typical 510(k) review window.

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 Kendall Healthcare Products Co. Div.Of Tyco Health devices

Submission Details

510(k) Number K970266 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 23, 1997
Decision Date April 23, 1997
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -