Cleared Traditional

K161606 - Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH

K161606 is an FDA 510(k) clearance for Syringe with fixed needle - For use onl..., manufactured by Terumo Europe N.V.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K161606 · Terumo Europe N.V. · General Hospital
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Feb 2017
Decision
245d
Days
Class 2
Risk

K161606 is an FDA 510(k) clearance for the Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Terumo Europe N.V. (Leuven, BE). The FDA issued a Cleared decision on February 10, 2017 after a review of 245 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Terumo Europe N.V. devices

FDA 510(k) Submission Details - K161606

510(k) Number K161606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2016
Decision Date February 10, 2017
Days to Decision 245 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 129d · This submission: 245d
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 480
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K161606.
Freedom Syringe
K161812 · Procedure Products, Inc. · Mar 2017
Sterile Single-use Syringe with Needle
K163161 · Jiangxi Hongda Medical Equipment Group , Ltd. · Mar 2017
Vesco Medical NRFit Tip Syringes
K170218 · Vesco Medical, LLC · Feb 2017
ConceptoMed Luer-Jack Slip 10ml
K162057 · Conceptomed AS · Jan 2017
Disposable Insulin Syringe
K162180 · Berpu Medical Technology Co., Ltd. · Dec 2016
BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe
K162081 · Becton, Dickinson and Company · Dec 2016