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FDA 510(k)

ARTIGLASS L. O.R. GLASS SYRINGE

K-Number: K122416 · 2013-05-03

ApplicantArtiglass Srl
Decision Date2013-05-03
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ARTIGLASS L. O.R. GLASS SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Artiglass Srl. It received FDA 510(k) clearance on 2013-05-03 under 510(k) number K122416. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTIGLASS L. O.R. GLASS SYRINGE?

ARTIGLASS L. O.R. GLASS SYRINGE is a medical device that received FDA 510(k) clearance on 2013-05-03. The listed applicant is Artiglass Srl. The 510(k) number is K122416.

When did ARTIGLASS L. O.R. GLASS SYRINGE receive FDA 510(k) clearance?

ARTIGLASS L. O.R. GLASS SYRINGE received FDA 510(k) clearance on 2013-05-03, under 510(k) number K122416.

Who is the listed applicant for ARTIGLASS L. O.R. GLASS SYRINGE?

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

What is the FDA product code for ARTIGLASS L. O.R. GLASS SYRINGE?

The FDA product code for ARTIGLASS L. O.R. GLASS SYRINGE is FMF.

Related Clinical Trials

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.

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Other records listing Artiglass Srl as applicant

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.

K213800Artiglass NRFitTM Tip L.O.R. Glass Syringes

Related Devices (Code: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

Official Source

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

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