FDA 510(k)

SafeR Syringe and SafeR Sting

Numéro K : K221981 · 2022-12-29

Date de décision2022-12-29

Code produitMEG

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositifs connexes (Code : MEG)

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 Corporation K231907Medline Safety Insulin and TB SyringesMedline Industries, LP K223376Monoject 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

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.