Cleared Traditional

K942824 - LORREX IV SPONGES

Also marketed or referenced as:
LORREX DRAIN SPONGES, STERILE 2'S
K942824 · Lorrex Health Products · General & Plastic Surgery device
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Aug 1994
Decision
50d
Days
-
Risk

K942824 is an FDA 510(k) clearance for the LORREX IV SPONGES, STERILE 2'S. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Lorrex Health Products (Secaucus, US). The FDA issued a Cleared decision on August 3, 1994 after a review of 50 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 Lorrex Health Products devices

FDA 510(k) Submission Details - K942824

510(k) Number K942824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1994
Decision Date August 03, 1994
Days to Decision 50 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
65d faster than avg
Panel avg: 115d · This submission: 50d
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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