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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 the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporaton. It received FDA 510(k) clearance on 2023-01-11 under 510(k) 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. The listed applicant is Fujifilm Corporaton. The 510(k) number is K223295.

When did Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D receive FDA 510(k) clearance?

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 510(k) number K223295.

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

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

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.

Other records listing Fujifilm Corporaton 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.

K221551FUJIFILM Endoscope Model EI-740D/SK220957FUJIFILM Endoscope Model EB-710PK212950FUJIFILM Video Laparoscope EL-R740M30K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0K200973Synapse 3D Cardiac Tools

Related Devices (Code: FDA)

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.

K260314Ancora-SBAspero Medical, Inc.K251204FUJIFILM Stiffening Wire Device (SW-2000)FUJIFILM Healthcare Americas CorporationK233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas CorporationK231323Ancora-SBAspero Medical, Inc.K213195Balloon BS-3Fujifilm CorporationK191330Arc EnterocuffBoddingtons Plastics, Ltd.

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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