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)

CHIRANA Insulin Syringes

K-Number: K201044 · 2022-01-18

ApplicantChirana T. Injecta
Decision Date2022-01-18
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CHIRANA Insulin Syringes is the device name listed in this FDA 510(k) record. The listed applicant is Chirana T. Injecta. It received FDA 510(k) clearance on 2022-01-18 under 510(k) number K201044. 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 CHIRANA Insulin Syringes?

CHIRANA Insulin Syringes is a medical device that received FDA 510(k) clearance on 2022-01-18. The listed applicant is Chirana T. Injecta. The 510(k) number is K201044.

When did CHIRANA Insulin Syringes receive FDA 510(k) clearance?

CHIRANA Insulin Syringes received FDA 510(k) clearance on 2022-01-18, under 510(k) number K201044.

Who is the listed applicant for CHIRANA Insulin Syringes?

The FDA 510(k) record lists Chirana T. Injecta as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHIRANA Insulin Syringes?

The FDA product code for CHIRANA Insulin Syringes is FMF.

Other records listing Chirana T. Injecta as applicant

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.

K242434Insulin SyringesK220614MEDOJECT fine Pen NeedlesK201009CHIRAVAC Blood Collection Needles

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.

↑