Disposable Sterile Syringe, Disposable Sterile Syringe with Needle— 510(k) K210991

Substantially Equivalent

Guangdong Antmed Co., Ltd.

FDA 510(k) clearance K210991 for Disposable Sterile Syringe, Disposable Sterile Syringe with Needle, Substantially Equivalent on 2021-08-26. Applicant: Guangdong Antmed Co., Ltd..

Clearance details

Applicant: Guangdong Antmed Co., Ltd.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2021-04-02
Decision date: 2021-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dongguan, 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.