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FDA 510(k)

DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE

K-Number: K034004 · 2004-03-03

ApplicantGyrus Ent LLC
Decision Date2004-03-03
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Ent LLC. It received FDA 510(k) clearance on 2004-03-03 under 510(k) number K034004. 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 DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE?

DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE is a medical device that received FDA 510(k) clearance on 2004-03-03. The listed applicant is Gyrus Ent LLC. The 510(k) number is K034004.

When did DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE receive FDA 510(k) clearance?

DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE received FDA 510(k) clearance on 2004-03-03, under 510(k) number K034004.

Who is the listed applicant for DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE?

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

What is the FDA product code for DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE?

The FDA product code for DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE is ERL.

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Other records listing Gyrus Ent LLC 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.

K040996RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEMK033089HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEMK033554SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESISK030343DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACEK021595GYRUS ENT NERVE STIMULATORK021777GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)

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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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