Cleared Traditional

K940756 - ISOLYSER (X-RAY DETECTABLE)

K940756 is an FDA 510(k) clearance for ISOLYSER (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 73-day FDA review.

K940756 · Thantex Specialties, Inc. · General & Plastic Surgery device
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May 1994
Decision
73d
Days
Class 1
Risk

K940756 is an FDA 510(k) clearance for the ISOLYSER (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 May 2, 1994 after a review of 73 days - a notably fast clearance cycle.

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: 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 Thantex Specialties, Inc. devices

FDA 510(k) Submission Details - K940756

510(k) Number K940756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1994
Decision Date May 02, 1994
Days to Decision 73 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
42d faster than avg
Panel avg: 115d · This submission: 73d
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 K940756.
OREX (12X12 X-RAY DETECTABLE)
K940767 · 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 (4X18) X-RAY DETECTABLE
K940757 · Thantex Specialties, Inc. · May 1994
ISOLYSER (18X18 X-RAY DETECTABLE)
K940762 · Thantex Specialties, Inc. · May 1994
ISOLYSER (8X4 12 PLY X-RAY DETECTABLE)
K940763 · Thantex Specialties, Inc. · May 1994