Cleared Traditional

K990584 - GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE

K990584 · Broadline Medical Industries · General & Plastic Surgery device
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Apr 1999
Decision
59d
Days
-
Risk

K990584 is an FDA 510(k) clearance for the GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Broadline Medical Industries (Inverness, US). The FDA issued a Cleared decision on April 23, 1999 after a review of 59 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.

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FDA 510(k) Submission Details - K990584

510(k) Number K990584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1999
Decision Date April 23, 1999
Days to Decision 59 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 115d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

EFQ Device Classification - Class 0,

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

All 140
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K980791 · Dumex Medical Surgical Products, Ltd. · Apr 1998