Cleared Traditional

K060211 - WUZHOU SYRINGE, WITH/WITHOUT NEEDLE

K060211 is an FDA 510(k) clearance for WUZHOU SYRINGE, manufactured by Wenzhou Wuzhou Group Co. , Ltd.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K060211 · Wenzhou Wuzhou Group Co. , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
14d
Days
Class 2
Risk

K060211 is an FDA 510(k) clearance for the WUZHOU SYRINGE, WITH/WITHOUT NEEDLE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Wenzhou Wuzhou Group Co. , Ltd. (Los Angeles, US). The FDA issued a Cleared decision on February 10, 2006 after a review of 14 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 Wenzhou Wuzhou Group Co. , Ltd. devices

FDA 510(k) Submission Details - K060211

510(k) Number K060211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2006
Decision Date February 10, 2006
Days to Decision 14 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 418
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K060211.
AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE
K061039 · Amsino International, Inc. · Jun 2006
TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES
K053413 · Terumo Europe N.V. · Apr 2006
MODIFICATION TO: VACLOK SYRINGE
K060095 · Wrightmedicaltechnologyinc · Feb 2006
B. BRAUN 0.2 MICRON FILTER
K052773 · B.Braun Medical, Inc. · Jan 2006
VITAGEL SURGICAL HEMOSTAT SPRAY SET
K052173 · Orthovita, Inc. · Oct 2005
NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE
K051574 · Nipro Medical Corp. · Aug 2005