Cleared Traditional

K915530 - NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE

K915530 is an FDA 510(k) clearance for NOVA GAUZE DISPOSABLE NONWOVEN SPONGES, manufactured by American Threshold Industries, Inc.. The device is a Class 2 Neurology device with product code HAX cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K915530 · American Threshold Industries, Inc. · Neurology device
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Aug 1992
Decision
251d
Days
Class 2
Risk

K915530 is an FDA 510(k) clearance for the NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE. Classified as Tong, Skull For Traction (product code HAX), Class II - Special Controls.

Submitted by American Threshold Industries, Inc. (Enka, US). The FDA issued a Cleared decision on August 17, 1992 after a review of 251 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5960 - the FDA neurology 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all American Threshold Industries, Inc. devices

FDA 510(k) Submission Details - K915530

510(k) Number K915530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1991
Decision Date August 17, 1992
Days to Decision 251 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 148d · This submission: 251d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAX Device Classification - Class 2, Special Controls

Product Code HAX Tong, Skull For Traction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5960
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - HAX Tong, Skull For Traction

All 11
Devices cleared under the same product code (HAX) and FDA review panel - the closest regulatory comparables to K915530.
RESOLVE OPEN BACK HALO RINGS
K051918 · Jerome Medical · Aug 2005
FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM
K980689 · Friddle'S Orthopedic Appliances, Inc. · Feb 1999
ACE CERVICAL TRACTION HALOZS, TONGS & PINS
K954069 · Ace Medical Co. · Oct 1995
PMT TRACTION TONGS
K871663 · Progress Mankind Technology · Jun 1987
MAYFIELD DISPOSABLE SKULL PINS
K853066 · Codman & Shurtleff, Inc. · Aug 1985
ACE UNIVERSAL TONG
K842680 · Buckman Co., Inc. · Sep 1984