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FDA 510(k)

Disposable Distal Attachment D-201 Series

K-Number: K250296 · 2025-05-01

ApplicantOlympus Medical Systems Corp.
Decision Date2025-05-01
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Distal Attachment D-201 Series is a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2025-05-01 under approval number K250296. 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 Attachment D-201 Series?

Disposable Distal Attachment D-201 Series is a medical device that received FDA 510(k) clearance on 2025-05-01. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K250296.

When was Disposable Distal Attachment D-201 Series approved by the FDA?

Disposable Distal Attachment D-201 Series received FDA 510(k) clearance on 2025-05-01, under approval number K250296.

What company makes Disposable Distal Attachment D-201 Series?

Disposable Distal Attachment D-201 Series is manufactured by Olympus Medical Systems Corp..

What is the FDA product code for Disposable Distal Attachment D-201 Series?

The FDA product code for Disposable Distal Attachment D-201 Series 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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