Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle— 510(k) K220204

Substantially Equivalent

Anhui Tiankang Medical Technology Co., Ltd.

FDA 510(k) clearance K220204 for Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle, Substantially Equivalent on 2022-07-14. Applicant: Anhui Tiankang Medical Technology Co., Ltd..

Clearance details

Applicant: Anhui Tiankang Medical Technology Co., Ltd.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2022-01-25
Decision date: 2022-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tianchang, 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.