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FDA 510(k)

Verisafe Safety Sterile Needles (SSN)

K-Number: K254273 · 2026-04-16

ApplicantPromisemed Hangzhou Meditech Co., Ltd.
Decision Date2026-04-16
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Verisafe Safety Sterile Needles (SSN) is a medical device manufactured by Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2026-04-16 under approval number K254273. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Verisafe Safety Sterile Needles (SSN)?

Verisafe Safety Sterile Needles (SSN) is a medical device that received FDA 510(k) clearance on 2026-04-16. It is manufactured by Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K254273.

When was Verisafe Safety Sterile Needles (SSN) approved by the FDA?

Verisafe Safety Sterile Needles (SSN) received FDA 510(k) clearance on 2026-04-16, under approval number K254273.

What company makes Verisafe Safety Sterile Needles (SSN)?

Verisafe Safety Sterile Needles (SSN) is manufactured by Promisemed Hangzhou Meditech Co., Ltd..

What is the FDA product code for Verisafe Safety Sterile Needles (SSN)?

The FDA product code for Verisafe Safety Sterile Needles (SSN) is FMI.

Related Clinical Trials

NCT06358391 To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access. RECRUITING NCT03228641 Evaluation of Safety and Efficacy of Micro-coring Device for Treatment of Facial Wrinkles and Skin Laxity COMPLETED

Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

Other Devices by Promisemed Hangzhou Meditech Co., Ltd.

K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle K193009Promisemed Heel Blood Lancet K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet K191853Dual-Safety Pen Needle K202681Promisemed Covered Safety Pen Needle K202682Promisemed Triple Safety Pen Needle

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Related Devices (Code: FMI)

K162516BD Pen NeedleBecton, Dickinson and Company K160532Greiner HoldexGreiner Bio-One Na, Inc. K160199Advocate Insulin Pen NeedlesDiabetic Supply of Suncoast, Inc. K151090CPL Insulin Pen NeedleCpl Co., Ltd. K160575CareSens Pen Needle, Softip Pen NeedleYidobio, Inc. K153706Insulin Pen NeedleSteriLance Medical (Suzhou), 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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