Cleared Traditional

K964060 - COPAXONE (COPOLYMER-1 FOR INJECTION) SELF-INJECTION ADMINISTRATION PACKAGE

K964060 is an FDA 510(k) clearance for COPAXONE (COPOLYMER-1 FOR INJECTION) SE..., manufactured by Travenol Laboratories (Israel) , Ltd.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K964060 · Travenol Laboratories (Israel) , Ltd. · General Hospital
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Dec 1996
Decision
76d
Days
Class 2
Risk

K964060 is an FDA 510(k) clearance for the COPAXONE (COPOLYMER-1 FOR INJECTION) SELF-INJECTION ADMINISTRATION PACKAGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Travenol Laboratories (Israel) , Ltd. (Kiriat Shemona, IL). The FDA issued a Cleared decision on December 24, 1996 after a review of 76 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 Travenol Laboratories (Israel) , Ltd. devices

FDA 510(k) Submission Details - K964060

510(k) Number K964060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1996
Decision Date December 24, 1996
Days to Decision 76 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
53d faster than avg
Panel avg: 129d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 416
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K964060.
RAMY INTEGRATED NEEDLE SYRINGE
K972452 · Alshifa Medical Syringes Mfg. Co., Ltd. · Jul 1997
BRANNON ARTERIO-VENOUS PORTSYRINGE
K965030 · Vascular Logics, Inc. · Mar 1997
OMNICAN SYRINGE
K962084 · B. Braun Medical AG · Feb 1997
IRT LOCKING SYRINGE
K945410 · Interventional Research Technologies · Dec 1996
DRESSING CHANGE TRAYS
K963260 · Busse Hospital Disposables, Inc. · Nov 1996
GLASS SYRINGE
K962042 · Ispg, Inc. · Oct 1996