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FDA 510(k)

STRYKER ESSX MICRODEBRIDER SYSTEM

K-Number: K073633 · 2008-08-26

ApplicantStryker Ireland Ltd., Instruments Division
Decision Date2008-08-26
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

STRYKER ESSX MICRODEBRIDER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Ireland Ltd., Instruments Division. It received FDA 510(k) clearance on 2008-08-26 under 510(k) number K073633. 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 STRYKER ESSX MICRODEBRIDER SYSTEM?

STRYKER ESSX MICRODEBRIDER SYSTEM is a medical device that received FDA 510(k) clearance on 2008-08-26. The listed applicant is Stryker Ireland Ltd., Instruments Division. The 510(k) number is K073633.

When did STRYKER ESSX MICRODEBRIDER SYSTEM receive FDA 510(k) clearance?

STRYKER ESSX MICRODEBRIDER SYSTEM received FDA 510(k) clearance on 2008-08-26, under 510(k) number K073633.

Who is the listed applicant for STRYKER ESSX MICRODEBRIDER SYSTEM?

The FDA 510(k) record lists Stryker Ireland Ltd., Instruments Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRYKER ESSX MICRODEBRIDER SYSTEM?

The FDA product code for STRYKER ESSX MICRODEBRIDER SYSTEM is ERL.

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_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Stryker Ireland Ltd., Instruments Division 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.

K082010STRYKER DISPOSABLE CRANIAL PERFORATOR BIT

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.K221184ORiGO SystemBien-Air Surgery SAK213221AMADEO, 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 Corporation

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.

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