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FDA 510(k)

Nutricair Enteral Syringe with ENFit

K-Number: K231300 · 2023-10-06

ApplicantCair Lgl
Decision Date2023-10-06
Product CodePNR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Nutricair Enteral Syringe with ENFit is the device name listed in this FDA 510(k) record. The listed applicant is Cair Lgl. It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K231300. The device is classified under product code PNR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nutricair Enteral Syringe with ENFit?

Nutricair Enteral Syringe with ENFit is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is Cair Lgl. The 510(k) number is K231300.

When did Nutricair Enteral Syringe with ENFit receive FDA 510(k) clearance?

Nutricair Enteral Syringe with ENFit received FDA 510(k) clearance on 2023-10-06, under 510(k) number K231300.

Who is the listed applicant for Nutricair Enteral Syringe with ENFit?

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

What is the FDA product code for Nutricair Enteral Syringe with ENFit?

The FDA product code for Nutricair Enteral Syringe with ENFit is PNR.

Other records listing Cair Lgl 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.

K231299Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connectorK213258Nasogastric Feeding Tubes - ENFit Port - PVCK210598Pediatric Nasogastric Feeding Tubes - Single ENFit PortK171117Carefusion NeutraClear Needle-free connector (EL-NC1000)K171118Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)K171132Carefusion NeutraClear Needle-free connector

View all 7 devices →

Related Devices (Code: PNR)

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.

K252483Enteral Syringe (20ml, 60ml)Chirana T.Injecta,A.S.K253268Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes CapCMT Health PTE., Ltd.K251585Profoject™ Enteral Feeding SyringeCMT Health PTE., Ltd.K243652Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE)CardinalhealthK222772Oral/Enteral Syringe with ENFit connectorAnhui Tiankang Medical Technology Co., Ltd.K211661ENFit enteral syringes (NUTRIFIT)Pentaferte Italia S.R.L.

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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