Diego RF Powered Dissector and Drill System Console
FDA 510(k) K034004 · Gyrus Ent LLC
510(k) numberK034004
Submission
- Device name
- Diego RF Powered Dissector and Drill System Console
- Applicant
- Gyrus Ent LLC
Bartlett, TN, US - Received
- December 24, 2003
- Decision date
- March 3, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ERL – Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4250
- Specialty
- Ear, Nose, Throat
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| K233958 | hekaDrillERL · Traditional | Zethon, Ltd. | 03/14/2024SE |
| K221184 | ORiGO SystemERL · Traditional | Bien-Air Surgery SA | 11/02/2022SE |
| K213221 | AMADEO, M-UK1015 (incl. attachments and accessories)ERL · Traditional | W&H Dentalwerk Buermoss GmbH | 05/26/2022SE |
| K212650 | Celeris, Disposable Sinus DebriderERL · Traditional | Gyrus Acmi, Inc. | 01/19/2022SE |
| K211490 | Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number…ERL · Special | Stryker Corporation | 06/09/2021SE |
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| K190715 | EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set…ERL · Traditional | Interscope, Inc. | 12/13/2019SE |
| K180063 | OCM-G1 AttachmentERL · Special | The Anspach Effort, Inc. | 03/27/2018SE |
| K171840 | Stryker Consolidated Operating Room Equipment (CORE) 2 ConsoleERL · Traditional | Stryker Corporation | 09/15/2017SE |
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| K040996 | Retrox Titanium Tube System for the Retrox Transcutaneous Air Conduction Hearing Aid…NIX · Traditional | 08/20/2004SE |
| K033089 | Hemostatix, Model 2400Z Thermal Scalpel SystemGEI · Traditional | 02/05/2004SE |
| K033554 | Smart Offset Stapes Piston; Smart Isj ProsthesisETB · Traditional | 11/24/2003SE |
| K030343 | Diego Powered Dissector Handpiece with Starlink Image-Guided Adapter Mounting InterfaceHAW · Traditional | 05/02/2003SE |
| K021595 | Gyrus ENT Nerve StimulatorETN · Traditional | 10/24/2002SE |
| K021777 | Gyrus ENT Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…GEI · Traditional | 08/26/2002SE |
| K020778 | Gyrus ENT Somnoplasty Tissue Coagulating Electrode, Model 2420GEI · Traditional | 05/28/2002SE |
| K020067 | Gyrus ENT Somnoplasty GeneratorGEI · Traditional | 04/04/2002SE |
| K020594 | Diego Powered Dissector and Drill SystemERL · Traditional | 03/08/2002SE |
| K003214 | Smith & Nephew PistonsETB · Traditional | 10/31/2000SE |
Questions and answers
When was Diego RF Powered Dissector and Drill System Console cleared by the FDA?
Diego RF Powered Dissector and Drill System Console (K034004) received a 510(k) decision of Substantially Equivalent on March 3, 2004, 70 days after the submission was received.
What is the product code of K034004?
The FDA product code is ERL – Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, a Class II (moderate risk) device regulated under 21 CFR 874.4250.