Cleared Traditional

OREX (12X12 X-RAY DETECTABLE) (K940767) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K940767 · Thantex Specialties, Inc. · General & Plastic Surgery device
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Dec 1994
Decision
304d
Days
Class 1
Risk

K940767 is an FDA 510(k) clearance for the OREX (12X12 X-RAY DETECTABLE). Classified as Gauze/sponge, Internal, X-ray Detectable (product code GDY), Class I - General Controls.

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, regulated under 21 CFR 878.4450 - the FDA general and plastic surgery device framework. 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 K940767 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 GDY Gauze/sponge, Internal, X-ray Detectable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4450
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.