FDA 510(k)

Sol-M Luer Lock Syringe

K-Number: K222744 · 2022-10-11

Decision Date2022-10-11

Product CodeFMF

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Sol-M Luer Lock Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Sol-Millennium Medical, Inc.. It received FDA 510(k) clearance on 2022-10-11 under 510(k) number K222744. 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 Sol-M Luer Lock Syringe?

Sol-M Luer Lock Syringe is a medical device that received FDA 510(k) clearance on 2022-10-11. The listed applicant is Sol-Millennium Medical, Inc.. The 510(k) number is K222744.

When did Sol-M Luer Lock Syringe receive FDA 510(k) clearance?

Sol-M Luer Lock Syringe received FDA 510(k) clearance on 2022-10-11, under 510(k) number K222744.

Who is the listed applicant for Sol-M Luer Lock Syringe?

The FDA 510(k) record lists Sol-Millennium Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sol-M Luer Lock Syringe?

The FDA product code for Sol-M Luer Lock Syringe is FMF.

Other records listing Sol-Millennium Medical, Inc. 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.

K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe K250907Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set K242291SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle K242099Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle K241821Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle K220713Sol-Guard Auto-disable Syringe

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Related Devices (Code: FMF)

K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC K253110Sol-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.K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd.K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.

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.