SafeR Syringe and SafeR Sting— 510(k) K221981

Name: FDA 510(k) clearance K221981
Creator: U.S. Food and Drug Administration
Published: 2022-12-29

Substantially Equivalent

Roncadelle Operations Srl

FDA 510(k) clearance K221981 for SafeR Syringe and SafeR Sting, Substantially Equivalent on 2022-12-29. Applicant: Roncadelle Operations Srl. Device class: 2.

Clearance details

Applicant: Roncadelle Operations Srl
Product code: Code MEG
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2022-07-05
Decision date: 2022-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castel Mella (Brescia), IT

Download summary PDF View on FDA.gov ↗

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K231907 — Medline Safety Insulin and TB Syringes2023-10-18

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.