Safety Blood Collection Set— 510(k) K163093

Clearance details

Applicant

Jiangsu Shenli Medical Production Co., Ltd.

Product code

Code FMI

Device class

Class 2

Regulation

21 CFR 880.5570

Advisory panel

General Hospital

Date received

2016-11-04

Decision date

2017-03-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Changzhou City, CN

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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 →