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FDA 510(k)

Ultra-Fine™ SAFETY Insulin Syringe

K-Number: K260208 · 2026-07-13

Applicantembecta Medical II, LLC
Decision Date2026-07-13
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Ultra-Fine™ SAFETY Insulin Syringe is the device name listed in this FDA 510(k) record. The listed applicant is embecta Medical II, LLC. It received FDA 510(k) clearance on 2026-07-13 under 510(k) number K260208. 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 Ultra-Fine™ SAFETY Insulin Syringe?

Ultra-Fine™ SAFETY Insulin Syringe is a medical device that received FDA 510(k) clearance on 2026-07-13. The listed applicant is embecta Medical II, LLC. The 510(k) number is K260208.

When did Ultra-Fine™ SAFETY Insulin Syringe receive FDA 510(k) clearance?

Ultra-Fine™ SAFETY Insulin Syringe received FDA 510(k) clearance on 2026-07-13, under 510(k) number K260208.

Who is the listed applicant for Ultra-Fine™ SAFETY Insulin Syringe?

The FDA 510(k) record lists embecta Medical II, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultra-Fine™ SAFETY Insulin Syringe?

The FDA product code for Ultra-Fine™ SAFETY Insulin Syringe is FMF.

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.

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.K253068Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin SyringeCMT Health PTE., Ltd.K253769Instylla Delivery KitInstylla, Inc.

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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