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FDA 510(k)

Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D

K-Number: K223295 · 2023-01-11

ApplicantFujifilm Corporaton
Decision Date2023-01-11
Product CodeFDA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D is a medical device manufactured by Fujifilm Corporaton. It received FDA 510(k) clearance on 2023-01-11 under approval number K223295. The device is classified under product code FDA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D?

Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D is a medical device that received FDA 510(k) clearance on 2023-01-11. It is manufactured by Fujifilm Corporaton. The 510(k) number is K223295.

When was Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D approved by the FDA?

Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D received FDA 510(k) clearance on 2023-01-11, under approval number K223295.

What company makes Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D?

Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D is manufactured by Fujifilm Corporaton.

What is the FDA product code for Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D?

The FDA product code for Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D is FDA.

Related PubMed Literature

PMID: 41804390 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. Medical devices (Auckland, N.Z.) (2026) PMID: 41358283 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. medRxiv : the preprint server for health sciences (2025)

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Related Devices (Code: FDA)

K183032FUJIFILM Double Balloon Endoscope EI580BTFujifilm Corporation K183683FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5Fujifilm Corporation K191330Arc EnterocuffBoddingtons Plastics, Ltd. K213195Balloon BS-3Fujifilm Corporation K231323Ancora-SBAspero Medical, Inc. K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas Corporation

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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