FDA 510(k)

Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe

Numéro K : K253110 · 2026-06-18

Date de décision2026-06-18

Code produitFMF

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Sol-Glide Safety Needle; Sol-Glide Safety Needle with 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 2026-06-18 under 510(k) number K253110. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe?

Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Sol-Millennium Medical, Inc.. The 510(k) number is K253110.

When did Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe receive FDA 510(k) clearance?

Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe received FDA 510(k) clearance on 2026-06-18, under 510(k) number K253110.

Who is the listed applicant for Sol-Glide Safety Needle; Sol-Glide Safety Needle with 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-Glide Safety Needle; Sol-Glide Safety Needle with Syringe?

The FDA product code for Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe is FMF.

Essais cliniques associés

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Autres dossiers indiquant Sol-Millennium Medical, Inc. en tant que demandeur

K252184SOL-M Luer Lock Syringe with Exchangeable Needle Tray 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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Dispositifs connexes (Code : FMF)

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC K252184SOL-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, LLC 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.

Source officielle

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