Cleared Traditional

K943184 - LORREX HEALTH PROD COTTON FILLED SPONGE...

K943184 · Lorons International Corp. · General & Plastic Surgery device
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Aug 1994
Decision
33d
Days
-
Risk

K943184 is an FDA 510(k) clearance for the LORREX HEALTH PROD COTTON FILLED SPONGES STERILE 2'S. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Lorons International Corp. (Secaucus, US). The FDA issued a Cleared decision on August 3, 1994 after a review of 33 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 Lorons International Corp. devices

FDA 510(k) Submission Details - K943184

510(k) Number K943184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1994
Decision Date August 03, 1994
Days to Decision 33 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
82d faster than avg
Panel avg: 115d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

EFQ Device Classification - Class 0,

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

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