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FDA 510(k)

b-ONE® Bipolar Head

K-Number: K253357 · 2026-04-13

ApplicantB-One Ortho, Corp.
Decision Date2026-04-13
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

b-ONE® Bipolar Head is the device name listed in this FDA 510(k) record. The listed applicant is B-One Ortho, Corp.. It received FDA 510(k) clearance on 2026-04-13 under 510(k) number K253357. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the b-ONE® Bipolar Head?

b-ONE® Bipolar Head is a medical device that received FDA 510(k) clearance on 2026-04-13. The listed applicant is B-One Ortho, Corp.. The 510(k) number is K253357.

When did b-ONE® Bipolar Head receive FDA 510(k) clearance?

b-ONE® Bipolar Head received FDA 510(k) clearance on 2026-04-13, under 510(k) number K253357.

Who is the listed applicant for b-ONE® Bipolar Head?

The FDA 510(k) record lists B-One Ortho, Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for b-ONE® Bipolar Head?

The FDA product code for b-ONE® Bipolar Head is KWY.

Other records listing B-One Ortho, Corp. as applicant

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Related Devices (Code: KWY)

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.

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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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