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FDA 510(k)

Wishbone HAE

K-Number: K260096 · 2026-10-09

ApplicantWishbone SA
Decision Date2026-10-09
Product CodeNPM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Wishbone HAE is the device name listed in this FDA 510(k) record. The listed applicant is Wishbone SA. It received FDA 510(k) clearance on 2026-10-09 under 510(k) number K260096. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wishbone HAE?

Wishbone HAE is a medical device that received FDA 510(k) clearance on 2026-10-09. The listed applicant is Wishbone SA. The 510(k) number is K260096.

When did Wishbone HAE receive FDA 510(k) clearance?

Wishbone HAE received FDA 510(k) clearance on 2026-10-09, under 510(k) number K260096.

Who is the listed applicant for Wishbone HAE?

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

What is the FDA product code for Wishbone HAE?

The FDA product code for Wishbone HAE is NPM.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Other records listing Wishbone 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.

K211551Wishbone HA

Related Devices (Code: NPM)

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.

K254210REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)Hyundai Bioland Co., Ltd.K253723BOSSMedpark Co., Ltd.K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®Geistlich Pharma AGK251613SwissGraft XGeistlich Pharma AGK242510Geistlich Bio-Flow®Geistlich Pharma AGK240133Xenograft Bovine Bone ParticulateCollagen Solutions, LLC

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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