Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ENFit to ENFit Extension Sets

K-Number: K230326 · 2023-11-02

ApplicantVesco Medical
Decision Date2023-11-02
Product CodePIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENFit to ENFit Extension Sets is a medical device manufactured by Vesco Medical. It received FDA 510(k) clearance on 2023-11-02 under approval number K230326. 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 ENFit to ENFit Extension Sets?

ENFit to ENFit Extension Sets is a medical device that received FDA 510(k) clearance on 2023-11-02. It is manufactured by Vesco Medical. The 510(k) number is K230326.

When was ENFit to ENFit Extension Sets approved by the FDA?

ENFit to ENFit Extension Sets received FDA 510(k) clearance on 2023-11-02, under approval number K230326.

What company makes ENFit to ENFit Extension Sets?

ENFit to ENFit Extension Sets is manufactured by Vesco Medical.

What is the FDA product code for ENFit to ENFit Extension Sets?

The FDA product code for ENFit to ENFit Extension Sets is PIF.

Related Devices (Code: PIF)

K160642Medline ENFit SyringeMedline Industries, Inc. K161003EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit ConnectorBoston Scientific Corporation K151503NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBEGbuk Enteral Limited K170162Vesco Medical Nasoenteric Feeding TubesVesco Medical, LLC K170555U Deliver Bolink ENFit Enteral Feeding SetsU Deliver Medical, LLC K171347Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit ConnectionXeridiem Medical Devices

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.

↑