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FDA 510(k)

Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle

K-Number: K222852 · 2023-05-25

ApplicantNipro Medical Corporation
Decision Date2023-05-25
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Medical Corporation. It received FDA 510(k) clearance on 2023-05-25 under 510(k) number K222852. 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 Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle?

Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle is a medical device that received FDA 510(k) clearance on 2023-05-25. The listed applicant is Nipro Medical Corporation. The 510(k) number is K222852.

When did Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle receive FDA 510(k) clearance?

Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle received FDA 510(k) clearance on 2023-05-25, under 510(k) number K222852.

Who is the listed applicant for Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle?

The FDA 510(k) record lists Nipro Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle?

The FDA product code for Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle is FMI.

Other records listing Nipro Medical Corporation as applicant

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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.

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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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