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FDA 510(k)

OTS 25-L (100-5)

K-Number: K251310 · 2025-07-22

ApplicantOts Medical , Ltd.
Decision Date2025-07-22
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OTS 25-L (100-5) is the device name listed in this FDA 510(k) record. The listed applicant is Ots Medical , Ltd.. It received FDA 510(k) clearance on 2025-07-22 under 510(k) number K251310. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTS 25-L (100-5)?

OTS 25-L (100-5) is a medical device that received FDA 510(k) clearance on 2025-07-22. The listed applicant is Ots Medical , Ltd.. The 510(k) number is K251310.

When did OTS 25-L (100-5) receive FDA 510(k) clearance?

OTS 25-L (100-5) received FDA 510(k) clearance on 2025-07-22, under 510(k) number K251310.

Who is the listed applicant for OTS 25-L (100-5)?

The FDA 510(k) record lists Ots Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OTS 25-L (100-5)?

The FDA product code for OTS 25-L (100-5) is MBI.

Other records listing Ots Medical , Ltd. as applicant

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.

K241234OTS 25-L (100-5)K233429OTS 25 (100-1)

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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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