Cleared Traditional

SOLUSPONGE - S-99 (K901564) - FDA 510(k) Clearance

K901564 · Sie Medical Supply Co., Inc. · General & Plastic Surgery device
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Feb 1991
Decision
330d
Days
-
Risk

K901564 is an FDA 510(k) clearance for the SOLUSPONGE - S-99. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Sie Medical Supply Co., Inc. (New York, US). The FDA issued a Cleared decision on February 27, 1991 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Sie Medical Supply Co., Inc. devices

Submission Details

510(k) Number K901564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1990
Decision Date February 27, 1991
Days to Decision 330 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
215d slower than avg
Panel avg: 115d · This submission: 330d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class -
Definition To Temporarily Control Bleeding And Cover External Wounds.