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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 a medical device manufactured by Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2025-06-27 under approval 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. It is manufactured by Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K243388.

When was Disposable Distal Cap approved by the FDA?

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

What company makes Disposable Distal Cap?

Disposable Distal Cap is manufactured by Micro-Tech (Nanjing) Co., Ltd..

What is the FDA product code for Disposable Distal Cap?

The FDA product code for Disposable Distal Cap is FDS.

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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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