Cleared Traditional

OREX (K940716) - FDA 510(k) Clearance

K940716 · Thantex Specialties, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
304d
Days
-
Risk

K940716 is an FDA 510(k) clearance for the OREX. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Thantex Specialties, Inc. (Norcross, US). The FDA issued a Cleared decision on December 19, 1994 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Thantex Specialties, Inc. devices

Submission Details

510(k) Number K940716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1994
Decision Date December 19, 1994
Days to Decision 304 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
189d slower than avg
Panel avg: 115d · This submission: 304d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K940716.
ABSORBENT GAUZE ROLL
K885143 · Smith & Nephew, Inc. · Feb 1989
GAUZE SWABS, NON-STERILE
K885142 · Smith & Nephew, Inc. · Jan 1989
JOHNSON & JOHNSON FLUFF SPONGE
K881222 · Johnson & Johnson Professionals, Inc. · Mar 1988
AQUATULLE FINE MESH NON-ADHERING DRESSING
K872759 · Smith & Nephew, Inc. · Sep 1987
NU-GAUZE SPONGE
K821150 · Johnson & Johnson Professionals, Inc. · Aug 1982