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FDA 510(k)

Pediatric Nasogastric Feeding Tubes - Single ENFit Port

K-Number: K210598 · 2021-11-02

ApplicantCair Lgl
Decision Date2021-11-02
Product CodePIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Pediatric Nasogastric Feeding Tubes - Single ENFit Port is the device name listed in this FDA 510(k) record. The listed applicant is Cair Lgl. It received FDA 510(k) clearance on 2021-11-02 under 510(k) number K210598. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pediatric Nasogastric Feeding Tubes - Single ENFit Port?

Pediatric Nasogastric Feeding Tubes - Single ENFit Port is a medical device that received FDA 510(k) clearance on 2021-11-02. The listed applicant is Cair Lgl. The 510(k) number is K210598.

When did Pediatric Nasogastric Feeding Tubes - Single ENFit Port receive FDA 510(k) clearance?

Pediatric Nasogastric Feeding Tubes - Single ENFit Port received FDA 510(k) clearance on 2021-11-02, under 510(k) number K210598.

Who is the listed applicant for Pediatric Nasogastric Feeding Tubes - Single ENFit Port?

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 Pediatric Nasogastric Feeding Tubes - Single ENFit Port?

The FDA product code for Pediatric Nasogastric Feeding Tubes - Single ENFit Port is PIF.

Related Clinical Trials

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.

NCT05966311Pediatric Percutaneous Ultrasound Gastrostomy TechniqueRECRUITINGNCT06328985Intermittent Oro-esophageal Tube Feeding in Traumatic Brain Injury PatientsCOMPLETED

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 connectorK231300Nutricair Enteral Syringe with ENFitK213258Nasogastric Feeding Tubes - ENFit Port - PVCK171117Carefusion NeutraClear Needle-free connector (EL-NC1000)K171118Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)K171132Carefusion NeutraClear Needle-free connector

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Related Devices (Code: PIF)

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.

K254170Percutaneous Endoscopic Gastrostomy (PEG) KitDegania Silicone , Ltd.K242917Enteral Drainage System, Enteral Medicine strawHMC Premedical S.p.A.K250481Extension Feeding Set with ENFit™ ConnectorsSKY Medical, a.s.K240052Disposable Enteral Feeding SetsBeijing L&Z Medical Technology Development Co., Ltd.K233034Mobility+ Enteral Feeding System OTCRockfield MedicalK230326ENFit to ENFit Extension SetsVesco Medical

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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