Cleared Abbreviated

K041344 - OPEN BORE SYRINGE

K041344 is an FDA 510(k) clearance for OPEN BORE SYRINGE, manufactured by Isotis NV. The device is a Class 2 General Hospital device with product code FMF cleared through the Abbreviated 510(k) pathway after a 57-day FDA review.

K041344 · Isotis NV · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
57d
Days
Class 2
Risk

K041344 is an FDA 510(k) clearance for the OPEN BORE SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Isotis NV (Bilthoven, NL). The FDA issued a Cleared decision on July 16, 2004 after a review of 57 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K041344

510(k) Number K041344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2004
Decision Date July 16, 2004
Days to Decision 57 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 129d · This submission: 57d
Pathway characteristics
Standards-based clearance path.

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 639
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K041344.
ASPIREX - BONE MARROW ASPIRATE KIT
K041991 · Isotis Orthobiologics, Inc. · Sep 2004
SMITH & NEPHEW GRAFT DELIVERY SYSTEM
K041976 · Smith & Nephew, Inc. · Aug 2004
HEMAMYST SURGICAL APPLICATOR SYSTEM, MODEL H-AS01
K041504 · Haemacure Corp. · Aug 2004
CLIP-ON SPACER 20%
K041084 · Serono, Inc. · Jul 2004
PHYSICIAN INDUSTRIES' DURAMETER SYRINGE
K033739 · Physician Industries, Inc. · Jul 2004
AUTODETECT SYRINGE
K041590 · Indigo Orb, Inc. · Jun 2004
K041344 · OPEN BORE SYRINGE
Download PDF FDA Summary Isotis NV