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FDA 510(k)

Nouvo Safety Set

K-Number: K232234 · 2024-03-15

ApplicantPoly Medicure Limited
Decision Date2024-03-15
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nouvo Safety Set is a medical device manufactured by Poly Medicure Limited. It received FDA 510(k) clearance on 2024-03-15 under approval number K232234. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nouvo Safety Set?

Nouvo Safety Set is a medical device that received FDA 510(k) clearance on 2024-03-15. It is manufactured by Poly Medicure Limited. The 510(k) number is K232234.

When was Nouvo Safety Set approved by the FDA?

Nouvo Safety Set received FDA 510(k) clearance on 2024-03-15, under approval number K232234.

What company makes Nouvo Safety Set?

Nouvo Safety Set is manufactured by Poly Medicure Limited.

What is the FDA product code for Nouvo Safety Set?

The FDA product code for Nouvo Safety Set is FOZ.

Other Devices by Poly Medicure Limited

K231401Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva K230616Polyguard and Polyshield Safety IV Catheters K220312Polyfusion IV Administration Sets K252677Polyshield Safety IV Catheters K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)

Related Devices (Code: FOZ)

K162894AccuCath Intravascular CatheterC.R. Bard, Inc. K161779MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV CatheterMedsource International, LLC K162377PowerGlide Pro Midline CatheterC.R. Bard, Inc. K161866BioFlo Midline CatheterNavilyst Medical, Inc. K161777BD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc. K160592SUPERCATH 6Togo Medikit Co., 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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