510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213800Substantially Equivalent

Artiglass NRFitTM Tip L.O.R. Glass Syringes

Artiglass SRL, Due Carrare, IT / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213800 is the FDA 510(k) clearance record for Artiglass NRFitTM Tip L.O.R. Glass Syringes, a class II device, cleared for Artiglass Srl on under FDA product code QEH (Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact). FDA's definition for product code QEH reads: "A neuraxial piston syringe is intended to inject or withdraw fluid from the neuraxial space with neuraxial specific connections. This product code may include epidural, peripheral, subarachnoid/spinal block, intrathecal and/or...". FDA records list 2 510(k) clearances for Artiglass Srl, from to . As of , FDA records show no recalls naming K213800.

Clearance record

Decision date
Received
(164 days to decision)
Product code
QEH Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Artiglass Srl Via Piemonte 13, Due Carrare, IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QEH

Trailing 12 months

FDA records hold no clearances under product code QEH in the trailing twelve months.

FDA records show no clearances under product code QEH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QEH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260