FDA 510(k)

NanoPress 760A-BT (760A-BT)

K-Number: K254267 · 2026-02-24

Decision Date2026-02-24

Product CodeJOW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

NanoPress 760A-BT (760A-BT) is the device name listed in this FDA 510(k) record. The listed applicant is Mego Afek , Ltd.. It received FDA 510(k) clearance on 2026-02-24 under 510(k) number K254267. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NanoPress 760A-BT (760A-BT)?

NanoPress 760A-BT (760A-BT) is a medical device that received FDA 510(k) clearance on 2026-02-24. The listed applicant is Mego Afek , Ltd.. The 510(k) number is K254267.

When did NanoPress 760A-BT (760A-BT) receive FDA 510(k) clearance?

NanoPress 760A-BT (760A-BT) received FDA 510(k) clearance on 2026-02-24, under 510(k) number K254267.

Who is the listed applicant for NanoPress 760A-BT (760A-BT)?

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

What is the FDA product code for NanoPress 760A-BT (760A-BT)?

The FDA product code for NanoPress 760A-BT (760A-BT) is JOW.

Other records listing Mego Afek , 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.

K230385Ballancer Platinum (1222)

Related Devices (Code: JOW)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.