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Blood Collection Needle, Model 20g 21g 22g

FDA 510(k)

Class II (US FDA 510(k))

510(k) K073127

by Shandong Weigao Group Medical Polymer Co., Ltd.

Identifiers

510(k) Number
K073127 FDA 510(k)
FDA Product Code
FMI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5570 FDA 510(k)
Regulation Number
880.5570 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Puncture Needle designed for blood collection, classified under the FDA Product Code FMI. It features interchangeable gauge sizes—20G, 21G, and 22G—with color-coded identification for easy selection. The needle is intended for use with vacuum tubes to draw blood samples in clinical settings, ensuring efficient and precise venipuncture. Its construction prioritizes smooth penetration to minimize patient discomfort and reduce the risk of needlestick injuries during use.

The Blood Collection Needle, Models 20G, 21G, 22G is supplied as a sterile, single-use device for professional medical personnel in hospital or laboratory environments. It is not intended for MRI use and must be discarded after one-time use to comply with infection control protocols. The device holds an FDA 510(k) clearance (K073127) under the Traditional pathway, with a decision date of December 20, 2007. Storage instructions are not specified in the data but should follow standard sterile medical device protocols to maintain integrity.

Frequently asked questions

What are the gauge sizes and how are they identified?

This device offers three interchangeable gauge sizes: 20G, 21G, and 22G. Each gauge is color-coded to ensure quick and accurate selection by medical personnel during blood collection procedures.

Is this needle intended for reuse or single-use?

The Blood Collection Needle, Models 20G/21G/22G is explicitly designed for single-use only. Reuse is prohibited to comply with infection control protocols and prevent needlestick injuries.

What clinical settings is this needle intended for?

This needle is intended for use in hospital or laboratory environments by professional medical personnel. It is specifically designed for blood collection using vacuum tubes, ensuring efficient and precise venipuncture.

What safety features does this needle include?

The needle is engineered for smooth penetration to reduce patient discomfort and minimize the risk of needlestick injuries during use. Its single-use design further enhances safety by preventing cross-contamination.

How should this needle be stored?

While storage instructions are not explicitly detailed, standard sterile medical device protocols should be followed to maintain the needle’s integrity. This includes keeping it in a clean, dry environment, protected from contamination and physical damage.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G (K073127) — FDA 510 (k ..., Blood Collection Needle, Model 20g 21g 22g 510 (k) FDA Premarket ..., Puncture needle - WEGO Medical - blood collection / 22G / 21G, PDF 采血管样本--2024.2--没改 - WEGO Medical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shandong Weigao Group Medical Polymer Co., Ltd.

Sources (1)

  • FDA 510(k) K073127 24 fields · synced Oct 5, 2026