Cleared Traditional

K945960 - LORREX NON-WOVEN SPONGES NON-STERILE

K945960 · Lorons International Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
36d
Days
-
Risk

K945960 is an FDA 510(k) clearance for the LORREX NON-WOVEN SPONGES NON-STERILE, STERILE, DRESSINGS. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Lorons International Corp. (Secaucus, US). The FDA issued a Cleared decision on January 12, 1995 after a review of 36 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 - K945960

510(k) Number K945960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1994
Decision Date January 12, 1995
Days to Decision 36 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 115d · This submission: 36d
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 K945960.
KENDALL CURITY IODOFORM PACKING STRIP
K973763 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1997
PROFORE FOUR-LAYER BANDAGE SYSTEM KIT
K961775 · Smith & Nephew United, Inc. · Jul 1996
LESINSKI SURGICAL EAR DRESSING
K950906 · Microtek Medical, Inc. · Jun 1995
OREX
K940716 · Thantex Specialties, Inc. · Dec 1994
ISOLYSER
K940765 · Thantex Specialties, Inc. · Dec 1994
STERILE GAUZE PRODUCT LINE
K941455 · Cush Medical Products · May 1994