Cleared Traditional

K894226 - SILASTIC SOFT SHEETING

K894226 · Dow Corning Wright · General & Plastic Surgery device
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Jan 1990
Decision
198d
Days
-
Risk

K894226 is an FDA 510(k) clearance for the SILASTIC SOFT SHEETING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on January 3, 1990 after a review of 198 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 Dow Corning Wright devices

FDA 510(k) Submission Details - K894226

510(k) Number K894226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1989
Decision Date January 03, 1990
Days to Decision 198 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 115d · This submission: 198d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 225
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INCARE HOT/ICE ABSORBENT INTERFACE
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K891288 · 3M Company · Jun 1989