SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE— 510(k) K111841

Substantially Equivalent

Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd.

FDA 510(k) clearance K111841 for SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE, Substantially Equivalent on 2012-03-01. Applicant: Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd..

Clearance details

Applicant: Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2011-06-29
Decision date: 2012-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chengdu City, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.