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FDA 510(k)

DR Safety Syringe, Sterile Hypodermic needle for Single use

K-Number: K212226 · 2021-09-29

Decision Date2021-09-29
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DR Safety Syringe, Sterile Hypodermic needle for Single use is the device name listed in this FDA 510(k) record. The listed applicant is Zhuhai DR Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2021-09-29 under 510(k) number K212226. 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 DR Safety Syringe, Sterile Hypodermic needle for Single use?

DR Safety Syringe, Sterile Hypodermic needle for Single use is a medical device that received FDA 510(k) clearance on 2021-09-29. The listed applicant is Zhuhai DR Medical Instruments Co., Ltd.. The 510(k) number is K212226.

When did DR Safety Syringe, Sterile Hypodermic needle for Single use receive FDA 510(k) clearance?

DR Safety Syringe, Sterile Hypodermic needle for Single use received FDA 510(k) clearance on 2021-09-29, under 510(k) number K212226.

Who is the listed applicant for DR Safety Syringe, Sterile Hypodermic needle for Single use?

The FDA 510(k) record lists Zhuhai DR Medical Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DR Safety Syringe, Sterile Hypodermic needle for Single use?

The FDA product code for DR Safety Syringe, Sterile Hypodermic needle for Single use is MEG.

Other records listing Zhuhai DR Medical Instruments 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.

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.