Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SafeR Syringe and SafeR Sting

K-Number: K221981 · 2022-12-29

ApplicantRoncadelle Operations Srl
Decision Date2022-12-29
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SafeR Syringe and SafeR Sting is the device name listed in this FDA 510(k) record. The listed applicant is Roncadelle Operations Srl. It received FDA 510(k) clearance on 2022-12-29 under 510(k) number K221981. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SafeR Syringe and SafeR Sting?

SafeR Syringe and SafeR Sting is a medical device that received FDA 510(k) clearance on 2022-12-29. The listed applicant is Roncadelle Operations Srl. The 510(k) number is K221981.

When did SafeR Syringe and SafeR Sting receive FDA 510(k) clearance?

SafeR Syringe and SafeR Sting received FDA 510(k) clearance on 2022-12-29, under 510(k) number K221981.

Who is the listed applicant for SafeR Syringe and SafeR Sting?

The FDA 510(k) record lists Roncadelle Operations Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SafeR Syringe and SafeR Sting?

The FDA product code for SafeR Syringe and SafeR Sting is MEG.

Related Devices (Code: MEG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252098PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)Methyl Co., Ltd.K250847VaporShieldVault Paragon Group, Inc.K230287SaviSafe Safety DeviceSuzhou Savicred Biotechnology Co., Ltd.K231165Shina Syringe; Shina Safety SyringeShina Med CorporationK231907Medline Safety Insulin and TB SyringesMedline Industries, LPK223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)Cardinal Health200, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑