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FDA 510(k)

Disposable Insulin Syringe

K-Number: K162180 · 2016-12-29

ApplicantBerpu Medical Technology Co., Ltd.
Decision Date2016-12-29
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Insulin Syringe 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 2016-12-29 under 510(k) number K162180. 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 Disposable Insulin Syringe?

Disposable Insulin Syringe is a medical device that received FDA 510(k) clearance on 2016-12-29. The listed applicant is Berpu Medical Technology Co., Ltd.. The 510(k) number is K162180.

When did Disposable Insulin Syringe receive FDA 510(k) clearance?

Disposable Insulin Syringe received FDA 510(k) clearance on 2016-12-29, under 510(k) number K162180.

Who is the listed applicant for Disposable Insulin Syringe?

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 Disposable Insulin Syringe?

The FDA product code for Disposable Insulin Syringe 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 needleK213811Sterile Hypodermic Syringes for Single UseK212514Safety Pen Needle for Single Use, Insulin Pen 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.

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.K253068Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin SyringeCMT Health PTE., 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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