Cleared Traditional

K961581 - EMERALD STERILE GAUZE SPONGE (FDA 510(k) Clearance)

K961581 · Emerald Medical, Inc. · General & Plastic Surgery device
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May 1996
Decision
34d
Days
-
Risk

K961581 is an FDA 510(k) clearance for the EMERALD STERILE GAUZE SPONGE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Emerald Medical, Inc. (Middlesex, US). The FDA issued a Cleared decision on May 28, 1996 after a review of 34 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 Emerald Medical, Inc. devices

Submission Details

510(k) Number K961581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1996
Decision Date May 28, 1996
Days to Decision 34 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
80d faster than avg
Panel avg: 114d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -