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FDA 510(k)

Disposable Distal Cap

K-Number: K243388 · 2025-06-27

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2025-06-27
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Distal Cap is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2025-06-27 under 510(k) number K243388. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Distal Cap?

Disposable Distal Cap is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K243388.

When did Disposable Distal Cap receive FDA 510(k) clearance?

Disposable Distal Cap received FDA 510(k) clearance on 2025-06-27, under 510(k) number K243388.

Who is the listed applicant for Disposable Distal Cap?

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

What is the FDA product code for Disposable Distal Cap?

The FDA product code for Disposable Distal Cap is FDS.

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Related Devices (Code: FDS)

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.

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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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