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FDA 510(k)

HUMMER IV MICRODEBRIDER SYSTEM

K-Number: K011381 · 2001-05-25

ApplicantStryker Instruments
Decision Date2001-05-25
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HUMMER IV MICRODEBRIDER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2001-05-25 under 510(k) number K011381. 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 HUMMER IV MICRODEBRIDER SYSTEM?

HUMMER IV MICRODEBRIDER SYSTEM is a medical device that received FDA 510(k) clearance on 2001-05-25. The listed applicant is Stryker Instruments. The 510(k) number is K011381.

When did HUMMER IV MICRODEBRIDER SYSTEM receive FDA 510(k) clearance?

HUMMER IV MICRODEBRIDER SYSTEM received FDA 510(k) clearance on 2001-05-25, under 510(k) number K011381.

Who is the listed applicant for HUMMER IV MICRODEBRIDER SYSTEM?

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

What is the FDA product code for HUMMER IV MICRODEBRIDER SYSTEM?

The FDA product code for HUMMER IV MICRODEBRIDER SYSTEM is ERL.

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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

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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