Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EpiZact

K-Number: K233056 · 2023-11-02

ApplicantGuidestar Medical Devices
Decision Date2023-11-02
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EpiZact is the device name listed in this FDA 510(k) record. The listed applicant is Guidestar Medical Devices. It received FDA 510(k) clearance on 2023-11-02 under 510(k) number K233056. 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 EpiZact?

EpiZact is a medical device that received FDA 510(k) clearance on 2023-11-02. The listed applicant is Guidestar Medical Devices. The 510(k) number is K233056.

When did EpiZact receive FDA 510(k) clearance?

EpiZact received FDA 510(k) clearance on 2023-11-02, under 510(k) number K233056.

Who is the listed applicant for EpiZact?

The FDA 510(k) record lists Guidestar Medical Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EpiZact?

The FDA product code for EpiZact 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.

K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-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

View on FDA Database →

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

↑