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FDA 510(k)

Sterile Hypodermic Syringes for Single Use

K-Number: K213811 · 2022-05-12

ApplicantBerpu Medical Technology Co., Ltd.
Decision Date2022-05-12
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Hypodermic Syringes for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Berpu Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-05-12 under 510(k) number K213811. 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?

Sterile Hypodermic Syringes for Single Use is a medical device that received FDA 510(k) clearance on 2022-05-12. The listed applicant is Berpu Medical Technology Co., Ltd.. The 510(k) number is K213811.

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

Sterile Hypodermic Syringes for Single Use received FDA 510(k) clearance on 2022-05-12, under 510(k) number K213811.

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

The FDA 510(k) record lists Berpu Medical Technology 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?

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

Other records listing Berpu Medical Technology 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.

K232165Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic NeedlesK221045Insulin Syringes without needleK220061Safety Insulin SyringesK213158Syringe with permanently attached needleK212514Safety Pen Needle for Single Use, Insulin Pen NeedlesK181447Safety insulin needle for single use

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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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