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FDA 510(k)

Over-tube (TR-1108A)

K-Number: K243091 · 2024-11-01

ApplicantFujifilm Corporation
Decision Date2024-11-01
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Over-tube (TR-1108A) is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2024-11-01 under 510(k) number K243091. 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-1108A)?

Over-tube (TR-1108A) is a medical device that received FDA 510(k) clearance on 2024-11-01. The listed applicant is Fujifilm Corporation. The 510(k) number is K243091.

When did Over-tube (TR-1108A) receive FDA 510(k) clearance?

Over-tube (TR-1108A) received FDA 510(k) clearance on 2024-11-01, under 510(k) number K243091.

Who is the listed applicant for Over-tube (TR-1108A)?

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

What is the FDA product code for Over-tube (TR-1108A)?

The FDA product code for Over-tube (TR-1108A) is FED.

Other records listing Fujifilm Corporation as applicant

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Related Devices (Code: FED)

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.

K260965CVAC Aspiration SystemCalyxo, Inc.K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.K252572Prodeon Urethral Sheath SystemProdeon Medical, Inc.K250128Single Use Suction-Evacuation Ureteral Access SheathAnhui Happiness Workshop Medical Instruments Co., Ltd.K250132Ureteral Access SheathZhejiang YiGao Medical Technology Co., Ltd.K250695Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., 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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