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FDA 510(k)

Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)

K-Number: K250187 · 2025-10-07

ApplicantOlympus Medical Systems Corporation
Decision Date2025-10-07
Product CodeKGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) is a medical device manufactured by Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2025-10-07 under approval number K250187. The device is classified under product code KGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)?

Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) is a medical device that received FDA 510(k) clearance on 2025-10-07. It is manufactured by Olympus Medical Systems Corporation. The 510(k) number is K250187.

When was Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) approved by the FDA?

Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) received FDA 510(k) clearance on 2025-10-07, under approval number K250187.

What company makes Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)?

Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) is manufactured by Olympus Medical Systems Corporation.

What is the FDA product code for Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)?

The FDA product code for Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) is KGE.

Related Clinical Trials

NCT06824402 Cryoprobe Biopsy and Chronic Rejection in Lung Transplant Recipients RECRUITING NCT05751278 Cryoprobe Versus Forceps for Transbronchial Biopsy COMPLETED

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Related Devices (Code: KGE)

K161186Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)Fujifilm Medical Systems U.S.A, Inc. K160625Disposable Hot Biopsy ForcepsMicro-Tech (Nanjing) Co., Ltd. K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)Fujifilm Medical System U.S.A., Inc. K171916Single Use Hot Biopsy Forceps FD-231Olympus Medical Systems Corp. K171096Fujifilm Diathermic Slitter (FlushKnife)Fujifilm Medical Systems U.S.A, Inc. K180018Disposable Hot Biopsy ForcepsMicro-Tech (Nanjing) 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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