Cleared Traditional

K861154 - ALBA HEALTH CARE PLAIN PACKING STRIP (FDA 510(k) Clearance)

K861154 · Alba Health Care · General & Plastic Surgery device
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Apr 1986
Decision
18d
Days
-
Risk

K861154 is an FDA 510(k) clearance for the ALBA HEALTH CARE PLAIN PACKING STRIP. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Alba Health Care (Valdese, US). The FDA issued a Cleared decision on April 15, 1986 after a review of 18 days - a notably fast clearance 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: 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 Alba Health Care devices

Submission Details

510(k) Number K861154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1986
Decision Date April 15, 1986
Days to Decision 18 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
96d faster than avg
Panel avg: 114d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -