Cleared Traditional

K974171 - COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS

K974171 is an FDA 510(k) clearance for COPAXONE (GLATIRAMER ACETATE FOR INJECT..., manufactured by Teva Medical, Ltd.. The device is a Class 2 General Hospital device with product code KZH cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K974171 · Teva Medical, Ltd. · General Hospital
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Dec 1997
Decision
44d
Days
Class 2
Risk

K974171 is an FDA 510(k) clearance for the COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS. Classified as Introducer, Syringe Needle (product code KZH), Class II - Special Controls.

Submitted by Teva Medical, Ltd. (Kulpsville, US). The FDA issued a Cleared decision on December 19, 1997 after a review of 44 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6920 - the FDA general hospital 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 Teva Medical, Ltd. devices

FDA 510(k) Submission Details - K974171

510(k) Number K974171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1997
Decision Date December 19, 1997
Days to Decision 44 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 129d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KZH Device Classification - Class 2, Special Controls

Product Code KZH Introducer, Syringe Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6920
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 General Hospital devices follow this clearance model.

Regulatory Peers - KZH Introducer, Syringe Needle

All 12
Devices cleared under the same product code (KZH) and FDA review panel - the closest regulatory comparables to K974171.
QUICK-SERTER, MODEL 395
K992300 · Medtronic Minimed · Jul 1999
AUTO-INJECTOR, SURE-INJECT 2000
K981266 · Mighty Mo, Corp. · Jul 1998
B-D AUTO-INJECTOR
K974678 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1998
MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300
K970479 · Medtronic Minimed · Mar 1997
V-CATH PERCUTANEOUS INTRODUCER KIT
K951384 · Hdc Corp. · Jun 1995
V-CATH BREAKAWAY NEEDLE INTRODUCER
K945473 · Hdc Corp. · Jan 1995