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FDA 510(k)

Sterile Safety Hypodermic Needles for Single Use

K-Number: K221080 · 2022-10-04

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

Device Summary

Sterile Safety Hypodermic Needles for Single Use 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 K221080. 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 Sterile Safety Hypodermic Needles for Single Use?

Sterile Safety Hypodermic Needles for Single Use 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 K221080.

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

Sterile Safety Hypodermic Needles for Single Use received FDA 510(k) clearance on 2022-10-04, under 510(k) number K221080.

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

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 Safety Hypodermic Needles for Single Use?

The FDA product code for Sterile Safety Hypodermic Needles for Single Use is FMI.

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 NeedlesK221079Sterile Hypodermic Syringes for Single UseK221073Sterile Hypodermic Syringes for Single Use with Safety NeedlesK221068Sterile Hypodermic Syringes for Single Use with Needles

View all 9 devices →

Related Devices (Code: FMI)

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.

K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.K254273Verisafe Safety Sterile Needles (SSN)Promisemed Hangzhou Meditech Co., Ltd.

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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