Cleared Traditional

HEMO-STAT (K922636) - FDA 510(k) Clearance

K922636 · Mckinley-Ross Laboratories, Inc. · General & Plastic Surgery device
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Nov 1992
Decision
164d
Days
-
Risk

K922636 is an FDA 510(k) clearance for the HEMO-STAT. Classified as Wound Dressings Containing Topical Analgesics (product code SEJ).

Submitted by Mckinley-Ross Laboratories, Inc. (Lynchburg, US). The FDA issued a Cleared decision on November 9, 1992 after a review of 164 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.

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Submission Details

510(k) Number K922636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1992
Decision Date November 09, 1992
Days to Decision 164 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 115d · This submission: 164d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code SEJ Wound Dressings Containing Topical Analgesics
Device Class -
Definition A Solid Wound Dressing Containing Topical Analgesics Is Used To Cover And Protect A Wound, To Absorb Exudate, To Maintain Appropriate Moisture Balance Within The Wound, And To Reduce Pain. A Wound Dressing Formulated As A Gel, Cream Or Ointment Containing Topical Analgesics Is Used To Maintain Appropriate Moisture Balance Within The Wound And To Reduce Pain.