Gyrus ENT Somnoplasty Tissue Coagulating Electrode, Model 2420
FDA 510(k) K020778 · Gyrus Ent LLC
510(k) numberK020778
Submission
- Device name
- Gyrus ENT Somnoplasty Tissue Coagulating Electrode, Model 2420
- Applicant
- Gyrus Ent LLC
Bartlett, TN, US - Received
- March 11, 2002
- Decision date
- May 28, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code GEI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254185 | Potenza PrimeGEI · Traditional | Jeisys Medical Incorporated | 09/11/2026SE |
| K262364 | Ellian Enigma RF DeviceGEI · Traditional | Ellian Corp | 09/02/2026SE |
| K253859 | Scarlet Pro (Scarlet Pro)GEI · Traditional | VIOL Co., Ltd. | 08/27/2026SE |
| K252535 | Inno-Switch Laparoscopic InstrumentsGEI · Traditional | Taiwan Surgical Corporation | 08/25/2026SE |
| K261179 | AlphaTriPart - Monopolar MIC InstrumentsGEI · Traditional | Gimmi GmbH | 07/22/2026SE |
| K253504 | VolnewmerGEI · Traditional | Classys, Inc. | 07/13/2026SE |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…GEI · Traditional | Olympus Medical Systems Corp. | 07/01/2026SE |
| K253484 | Lutronic GeniusGEI · Traditional | Cynosure Lutronic Technology Corporation | 06/29/2026SE |
| K251492 | Irrigation Tubing Bipolar Cord SetGEI · Traditional | New Deantronics Taiwan , Ltd. | 06/29/2026SE |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingGEI · Traditional | Stryker Sustainability Solutions | 06/18/2026SE |
More from Stryker Sustainability Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K040996 | Retrox Titanium Tube System for the Retrox Transcutaneous Air Conduction Hearing Aid…NIX · Traditional | 08/20/2004SE |
| K034004 | Diego RF Powered Dissector and Drill System ConsoleERL · Traditional | 03/03/2004SE |
| 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 |
| 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 Gyrus ENT Somnoplasty Tissue Coagulating Electrode, Model 2420 cleared by the FDA?
Gyrus ENT Somnoplasty Tissue Coagulating Electrode, Model 2420 (K020778) received a 510(k) decision of Substantially Equivalent on May 28, 2002, 78 days after the submission was received.
What is the product code of K020778?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.