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FDA 510(k)

Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection

K-Number: K232046 · 2023-10-06

ApplicantXeridiem Medical Devices, A Spectrum Plastics Group Company
Decision Date2023-10-06
Product CodePIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection is a medical device manufactured by Xeridiem Medical Devices, A Spectrum Plastics Group Company. It received FDA 510(k) clearance on 2023-10-06 under approval number K232046. 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 Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection?

Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection is a medical device that received FDA 510(k) clearance on 2023-10-06. It is manufactured by Xeridiem Medical Devices, A Spectrum Plastics Group Company. The 510(k) number is K232046.

When was Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection approved by the FDA?

Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection received FDA 510(k) clearance on 2023-10-06, under approval number K232046.

What company makes Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection?

Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection is manufactured by Xeridiem Medical Devices, A Spectrum Plastics Group Company.

What is the FDA product code for Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection?

The FDA product code for Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection is PIF.

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Other Devices by Xeridiem Medical Devices, A Spectrum Plastics Group Company

K180708Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit

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.

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