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FDA 510(k)

Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)

K-Number: K230752 · 2023-09-15

ApplicantFUJIFILM Healthcare Americas Corporation
Decision Date2023-09-15
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) is a medical device manufactured by FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2023-09-15 under approval number K230752. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)?

Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) is a medical device that received FDA 510(k) clearance on 2023-09-15. It is manufactured by FUJIFILM Healthcare Americas Corporation. The 510(k) number is K230752.

When was Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) approved by the FDA?

Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) received FDA 510(k) clearance on 2023-09-15, under approval number K230752.

What company makes Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)?

Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) is manufactured by FUJIFILM Healthcare Americas Corporation.

What is the FDA product code for Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)?

The FDA product code for Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) is FED.

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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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