Sterile Hypodermic Syringes for Single Use with Safety Needles— 510(k) K221073

Name: FDA 510(k) clearance K221073
Creator: U.S. Food and Drug Administration
Published: 2022-10-04

Substantially Equivalent

Sichuan Prius Biotechnology Co., Ltd.

FDA 510(k) clearance K221073 for Sterile Hypodermic Syringes for Single Use with Safety Needles, Substantially Equivalent on 2022-10-04. Applicant: Sichuan Prius Biotechnology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Sichuan Prius Biotechnology Co., Ltd.
Product code: Code MEG
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2022-04-12
Decision date: 2022-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yibin, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code MEG

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K230287 — SaviSafe Safety Device2023-11-21
K231165 — Shina Syringe; Shina Safety Syringe2023-10-27
K231907 — Medline Safety Insulin and TB Syringes2023-10-18

More clearances from Sichuan Prius Biotechnology Co., Ltd.

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K221069 — Infusion Sets for Single Use with Needles2022-11-21
K221075 — Infusion Sets for Single Use2022-11-21
K221078 — Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use2022-11-21
K221066 — Sterile Hypodermic Needles for Single Use2022-10-04
K221068 — Sterile Hypodermic Syringes for Single Use with Needles2022-10-04

Adverse events under product code MEG

product code MEG

Malfunction: 1,373
Other: 1
Total: 1,374

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.