Cleared Traditional

K942070 - LORREX COVER SPONGES STERILE2'S AND NON...

K942070 · Lorrex Health Products · General & Plastic Surgery device
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May 1994
Decision
20d
Days
-
Risk

K942070 is an FDA 510(k) clearance for the LORREX COVER SPONGES STERILE2'S AND NON-STERILE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Lorrex Health Products (Secaucus, US). The FDA issued a Cleared decision on May 19, 1994 after a review of 20 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 - K942070

510(k) Number K942070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1994
Decision Date May 19, 1994
Days to Decision 20 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
95d faster than avg
Panel avg: 115d · This submission: 20d
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 85
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K942070.
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ISOLYER (4X4, 12 PLY)
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TENDERBREDE(R) PACKING AND DEBRIDEMENT SPONGE
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VISITEC EYE PAD
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