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FDA 510(k)

ClearTip FNA and FNB Types

K-Number: K250994 · 2025-08-21

Decision Date2025-08-21
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ClearTip FNA and FNB Types is the device name listed in this FDA 510(k) record. The listed applicant is Finemedix Co., Ltd.. It received FDA 510(k) clearance on 2025-08-21 under 510(k) number K250994. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClearTip FNA and FNB Types?

ClearTip FNA and FNB Types is a medical device that received FDA 510(k) clearance on 2025-08-21. The listed applicant is Finemedix Co., Ltd.. The 510(k) number is K250994.

When did ClearTip FNA and FNB Types receive FDA 510(k) clearance?

ClearTip FNA and FNB Types received FDA 510(k) clearance on 2025-08-21, under 510(k) number K250994.

Who is the listed applicant for ClearTip FNA and FNB Types?

The FDA 510(k) record lists Finemedix Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClearTip FNA and FNB Types?

The FDA product code for ClearTip FNA and FNB Types is FCG.

Other records listing Finemedix Co., Ltd. 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.

View all 11 devices →

Related Devices (Code: FCG)

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.

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.