Cleared Traditional

K940767 - OREX (12X12 X-RAY DETECTABLE)

K940767 is an FDA 510(k) clearance for OREX (12X12 X-RAY DETECTABLE), manufactured by Thantex Specialties, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDY cleared through the Traditional 510(k) pathway after a 304-day FDA review.

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

FDA 510(k) Submission Details - K940767

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
189d slower than avg
Panel avg: 115d · This submission: 304d
Pathway characteristics
Predicate-based equivalence.

GDY Device Classification - Class 1, General Controls

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.

Regulatory Peers - GDY Gauze/sponge, Internal, X-ray Detectable

All 37
Devices cleared under the same product code (GDY) and FDA review panel - the closest regulatory comparables to K940767.
ULTRACELL RETRACTOR COVERS
K950659 · Ultracell Medical Technologies, Inc. · Apr 1995
OREX
K940764 · Thantex Specialties, Inc. · Dec 1994
OREX (18X18 X-RAY DETECTABLE)
K940766 · Thantex Specialties, Inc. · Dec 1994
LAP SPONGE PRODUCT LINE
K941344 · Cush Medical Products · May 1994
STERILE X-RAY DETECTABLE GAUZE SPONGES
K941522 · Cush Medical Products · May 1994
ISOLYSER (X-RAY DETECTABLE)
K940756 · Thantex Specialties, Inc. · May 1994