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FDA 510(k)

Sterile Hypodermic Syringes for Single Use with Needles

K-Number: K221068 · 2022-10-04

ApplicantSichuan Prius Biotechnology Co., Ltd.
Decision Date2022-10-04
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Hypodermic Syringes for Single Use with Needles is the device name listed in this FDA 510(k) record. The listed applicant is Sichuan Prius Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2022-10-04 under 510(k) number K221068. 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 Sterile Hypodermic Syringes for Single Use with Needles?

Sterile Hypodermic Syringes for Single Use with Needles is a medical device that received FDA 510(k) clearance on 2022-10-04. The listed applicant is Sichuan Prius Biotechnology Co., Ltd.. The 510(k) number is K221068.

When did Sterile Hypodermic Syringes for Single Use with Needles receive FDA 510(k) clearance?

Sterile Hypodermic Syringes for Single Use with Needles received FDA 510(k) clearance on 2022-10-04, under 510(k) number K221068.

Who is the listed applicant for Sterile Hypodermic Syringes for Single Use with Needles?

The FDA 510(k) record lists Sichuan Prius Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Hypodermic Syringes for Single Use with Needles?

The FDA product code for Sterile Hypodermic Syringes for Single Use with Needles is FMF.

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Other records listing Sichuan Prius Biotechnology Co., Ltd. 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.

K221078Intravenous Needles for Single Use,Safety Intravenous Needles for Single UseK221075Infusion Sets for Single UseK221069Infusion Sets for Single Use with NeedlesK221080Sterile Safety Hypodermic Needles for Single UseK221079Sterile Hypodermic Syringes for Single UseK221073Sterile Hypodermic Syringes for Single Use with Safety Needles

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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.

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