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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Tuv America, Inc.
LAURA DANIELSON

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FMF Syringe, Piston

All 688
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K060211.
HUMAPEN MEMOIR
K053563 · Eli Lilly and Company · Apr 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
ARTSANA PISTON AND INSULIN SYRINGES
K052667 · Artsana S.P.A · Nov 2005
PROCEDUR-10
K052075 · Avanca Medical Devices, Inc. · Nov 2005

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K060211 · WUZHOU SYRINGE, WITH/WITHOUT NEEDLE
Download PDF FDA Summary Wenzhou Wuzhou Group …