Artiglass NRFitTM Tip L.O.R. Glass Syringes— 510(k) K213800

Name: FDA 510(k) clearance K213800
Creator: U.S. Food and Drug Administration
Published: 2022-05-19

Substantially Equivalent

Artiglass Srl

FDA 510(k) clearance K213800 for Artiglass NRFitTM Tip L.O.R. Glass Syringes, Substantially Equivalent on 2022-05-19. Applicant: Artiglass Srl. Device class: 2.

Clearance details

Applicant: Artiglass Srl
Product code: Code QEH
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2021-12-06
Decision date: 2022-05-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Due Carrare, IT

Download summary PDF View on FDA.gov ↗

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K241385 — Omnifix Syringe NRFit2024-07-13
K201031 — NRFit® Caps, Male and Female Neuraxial Tip Caps2020-12-16
K192538 — BD Syringe NRFit Lok and BD Syringe NRFit Slip2020-09-04
K181374 — NRFit Syringe2018-12-14

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K122416 — ARTIGLASS L. O.R. GLASS SYRINGE2013-05-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.