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FDA 510(k)

Safety Insulin Syringes

K-Number: K220061 · 2022-08-23

ApplicantBerpu Medical Technology Co., Ltd.
Decision Date2022-08-23
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Safety Insulin Syringes 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 2022-08-23 under 510(k) number K220061. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Safety Insulin Syringes?

Safety Insulin Syringes is a medical device that received FDA 510(k) clearance on 2022-08-23. The listed applicant is Berpu Medical Technology Co., Ltd.. The 510(k) number is K220061.

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

Safety Insulin Syringes received FDA 510(k) clearance on 2022-08-23, under 510(k) number K220061.

Who is the listed applicant for Safety Insulin Syringes?

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 Safety Insulin Syringes?

The FDA product code for Safety Insulin Syringes is MEG.

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 needleK213158Syringe with permanently attached needleK213811Sterile Hypodermic Syringes for Single UseK212514Safety Pen Needle for Single Use, Insulin Pen NeedlesK181447Safety insulin needle for single use

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Related Devices (Code: MEG)

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.

K252098PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)Methyl Co., Ltd.K250847VaporShieldVault Paragon Group, Inc.K230287SaviSafe Safety DeviceSuzhou Savicred Biotechnology Co., Ltd.K231165Shina Syringe; Shina Safety SyringeShina Med CorporationK231907Medline Safety Insulin and TB SyringesMedline Industries, LPK223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)Cardinal Health200, LLC

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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