Disposable Insulin Syringe— 510(k) K162180

Substantially Equivalent

Berpu Medical Technology Co., Ltd.

FDA 510(k) clearance K162180 for Disposable Insulin Syringe, Substantially Equivalent on 2016-12-29. Applicant: Berpu Medical Technology Co., Ltd..

Clearance details

Applicant: Berpu Medical Technology Co., Ltd.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2016-08-04
Decision date: 2016-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wenzhou, 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.