BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G— 510(k) K073127

Clearance details

Applicant

Shandong Weigao Group Medical Polymer Co., Ltd.

Product code

Code FMI

Device class

Class 2

Regulation

21 CFR 880.5570

Advisory panel

General Hospital

Date received

2007-11-06

Decision date

2007-12-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shanghai, CN

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• K102741 — ENTERAL FEEDING BAG AND SETS2011-11-08
• K102328 — BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA2011-05-13
• K081241 — WEIGAO EMPTY CARTRIDGE SYRINGE2008-09-08

Death

28

Injury

1,517

Malfunction

23,981

Other

18

Total

25,544

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →