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FDA 510(k)

ORiGO System

K-Number: K221184 · 2022-11-02

ApplicantBien-Air Surgery SA
Decision Date2022-11-02
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ORiGO System is the device name listed in this FDA 510(k) record. The listed applicant is Bien-Air Surgery SA. It received FDA 510(k) clearance on 2022-11-02 under 510(k) number K221184. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORiGO System?

ORiGO System is a medical device that received FDA 510(k) clearance on 2022-11-02. The listed applicant is Bien-Air Surgery SA. The 510(k) number is K221184.

When did ORiGO System receive FDA 510(k) clearance?

ORiGO System received FDA 510(k) clearance on 2022-11-02, under 510(k) number K221184.

Who is the listed applicant for ORiGO System?

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

What is the FDA product code for ORiGO System?

The FDA product code for ORiGO System is ERL.

Other records listing Bien-Air Surgery 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.

K213697ORiGO SystemK173066OSSEODUO Shaver and Drill System

Related Devices (Code: ERL)

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.

K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)W&H Dentalwerk Buermoos GmbHK233958hekaDrillZethon, Ltd.K213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbHK212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000Stryker CorporationK200318UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver HandpieceKARL STORZ Endoscopy-America, Inc.

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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