Mis Electrosurgical Electrodes
FDA 510(k) K915788 · Beacon Laboratories, Inc.
510(k) numberK915788
Submission
- Device name
- Mis Electrosurgical Electrodes
- Applicant
- Beacon Laboratories, Inc.
Broomfield, CO, US - Received
- December 24, 1991
- Decision date
- March 13, 1992
- 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 |
|---|---|---|
| K930243 | Flexible ExtenderGEI · Traditional | 03/11/1994SE |
| K930497 | Argon HandpiecesGEI · Traditional | 06/25/1993SE |
| K925708 | Disposable Electrosurgery Ball ElectrodeDWG · Traditional | 04/20/1993SE |
| K922289 | Sesquipolar(Tm) Mis ElectrodeGEI · Traditional | 01/15/1993SE |
| K925619 | Disposable Hand-Switching Esu PencilGEI · Traditional | 12/24/1992SE |
| K920100 | Gsu Handpiece AdapterHAM · Traditional | 02/03/1992SE |
| K913772 | Pressure GuardHIF · Traditional | 11/19/1991SE |
| K905752 | Argon Beam Combo Laparoscopic ElectrodeGEI · Traditional | 07/22/1991SE |
| K904506 | Active AdapterGEI · Traditional | 12/13/1990SE |
| K902996 | Argon Beam Laparoscopic ElectrodeGEI · Traditional | 11/21/1990SE |
Questions and answers
When was Mis Electrosurgical Electrodes cleared by the FDA?
Mis Electrosurgical Electrodes (K915788) received a 510(k) decision of Substantially Equivalent on March 13, 1992, 80 days after the submission was received.
What is the product code of K915788?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.