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FDA 510(k)

Surgical Microscope (OMS2360, OMS2380)

K-Number: K252464 · 2026-04-28

ApplicantZumax Medical Co., Ltd.
Decision Date2026-04-28
Product CodeNBL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Surgical Microscope (OMS2360, OMS2380) is a medical device manufactured by Zumax Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-04-28 under approval number K252464. The device is classified under product code NBL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Surgical Microscope (OMS2360, OMS2380)?

Surgical Microscope (OMS2360, OMS2380) is a medical device that received FDA 510(k) clearance on 2026-04-28. It is manufactured by Zumax Medical Co., Ltd.. The 510(k) number is K252464.

When was Surgical Microscope (OMS2360, OMS2380) approved by the FDA?

Surgical Microscope (OMS2360, OMS2380) received FDA 510(k) clearance on 2026-04-28, under approval number K252464.

What company makes Surgical Microscope (OMS2360, OMS2380)?

Surgical Microscope (OMS2360, OMS2380) is manufactured by Zumax Medical Co., Ltd..

What is the FDA product code for Surgical Microscope (OMS2360, OMS2380)?

The FDA product code for Surgical Microscope (OMS2360, OMS2380) is NBL.

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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