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FDA 510(k)

Single Use Distal Cover MAJ-2315 (MAJ-2315)

K-Number: K253646 · 2026-02-22

ApplicantOlympus Medical Systems Corp.
Decision Date2026-02-22
Product CodeFDT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single Use Distal Cover MAJ-2315 (MAJ-2315) is a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2026-02-22 under approval number K253646. The device is classified under product code FDT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Single Use Distal Cover MAJ-2315 (MAJ-2315)?

Single Use Distal Cover MAJ-2315 (MAJ-2315) is a medical device that received FDA 510(k) clearance on 2026-02-22. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K253646.

When was Single Use Distal Cover MAJ-2315 (MAJ-2315) approved by the FDA?

Single Use Distal Cover MAJ-2315 (MAJ-2315) received FDA 510(k) clearance on 2026-02-22, under approval number K253646.

What company makes Single Use Distal Cover MAJ-2315 (MAJ-2315)?

Single Use Distal Cover MAJ-2315 (MAJ-2315) is manufactured by Olympus Medical Systems Corp..

What is the FDA product code for Single Use Distal Cover MAJ-2315 (MAJ-2315)?

The FDA product code for Single Use Distal Cover MAJ-2315 (MAJ-2315) is FDT.

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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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