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FDA 510(k)

Sol-Guard Auto-disable Syringe

K-Number: K220713 · 2023-05-04

ApplicantSol-Millennium Medical, Inc.
Decision Date2023-05-04
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sol-Guard Auto-disable Syringe is a medical device manufactured by Sol-Millennium Medical, Inc.. It received FDA 510(k) clearance on 2023-05-04 under approval number K220713. 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-Guard Auto-disable Syringe?

Sol-Guard Auto-disable Syringe is a medical device that received FDA 510(k) clearance on 2023-05-04. It is manufactured by Sol-Millennium Medical, Inc.. The 510(k) number is K220713.

When was Sol-Guard Auto-disable Syringe approved by the FDA?

Sol-Guard Auto-disable Syringe received FDA 510(k) clearance on 2023-05-04, under approval number K220713.

What company makes Sol-Guard Auto-disable Syringe?

Sol-Guard Auto-disable Syringe is manufactured by Sol-Millennium Medical, Inc..

What is the FDA product code for Sol-Guard Auto-disable Syringe?

The FDA product code for Sol-Guard Auto-disable Syringe is FMF.

Other Devices by Sol-Millennium Medical, Inc.

K1620300.5ml Sol-Care Retractable Safety Syringe with Fixed Needle K153537Sol-M Insulin Syringe, Sol-M TB Syringe K163073Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder K182146Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set K222744Sol-M Luer Lock Syringe K213718SOL-GUARD Safety Pull Button Collection Set

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Related Devices (Code: FMF)

K162180Disposable Insulin SyringeBerpu Medical Technology Co., Ltd. K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin SyringeBecton, Dickinson and Company K162602NovoPen EchoNovo Nordisk, Inc. K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. K152879Sure-Fine Insulin SyringesShina Med Corporation K160629InPenCompanion Medical, Inc.

Official Source

View on FDA Database →

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

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