FDA 510(k)

ZAFIRA®

K-Number: K254245 · 2026-03-03

Decision Date2026-03-03

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ZAFIRA® is the device name listed in this FDA 510(k) record. The listed applicant is New Stetic, SA. It received FDA 510(k) clearance on 2026-03-03 under 510(k) number K254245. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZAFIRA®?

ZAFIRA® is a medical device that received FDA 510(k) clearance on 2026-03-03. The listed applicant is New Stetic, SA. The 510(k) number is K254245.

When did ZAFIRA® receive FDA 510(k) clearance?

ZAFIRA® received FDA 510(k) clearance on 2026-03-03, under 510(k) number K254245.

Who is the listed applicant for ZAFIRA®?

The FDA 510(k) record lists New Stetic, SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZAFIRA®?

The FDA product code for ZAFIRA® is EBF.

Other records listing New Stetic, SA 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.

K192153Portux CAD/CAM Disc

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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.