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FDA 510(k)

Double Balloon Endoscope EN-840T, Over-tube TS-1214C

K-Number: K233321 · 2024-06-13

ApplicantFUJIFILM Healthcare Americas Corporation
Decision Date2024-06-13
Product CodeFDA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Double Balloon Endoscope EN-840T, Over-tube TS-1214C is a medical device manufactured by FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2024-06-13 under approval number K233321. 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 Double Balloon Endoscope EN-840T, Over-tube TS-1214C?

Double Balloon Endoscope EN-840T, Over-tube TS-1214C is a medical device that received FDA 510(k) clearance on 2024-06-13. It is manufactured by FUJIFILM Healthcare Americas Corporation. The 510(k) number is K233321.

When was Double Balloon Endoscope EN-840T, Over-tube TS-1214C approved by the FDA?

Double Balloon Endoscope EN-840T, Over-tube TS-1214C received FDA 510(k) clearance on 2024-06-13, under approval number K233321.

What company makes Double Balloon Endoscope EN-840T, Over-tube TS-1214C?

Double Balloon Endoscope EN-840T, Over-tube TS-1214C is manufactured by FUJIFILM Healthcare Americas Corporation.

What is the FDA product code for Double Balloon Endoscope EN-840T, Over-tube TS-1214C?

The FDA product code for Double Balloon Endoscope EN-840T, Over-tube TS-1214C is FDA.

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Related Devices (Code: FDA)

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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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