Lmi Medical, Electrode, Electrosurgical, Disposable Dispersive Electrode with Cord
FDA 510(k) K951328 · Labeltape Meditect, Inc.
510(k) numberK951328
Submission
- Device name
- Lmi Medical, Electrode, Electrosurgical, Disposable Dispersive Electrode with Cord
- Applicant
- Labeltape Meditect, Inc.
Grand Rapids, MI, US - Received
- March 23, 1995
- Decision date
- April 25, 1995
- 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 |
|---|---|---|
| K915333 | Electrode Using Promeon RG-60 Series GelGXY · Traditional | 01/14/1992SE |
| K914871 | Trans Elec Nerve Stim/Muscle Stim Elec W/Poly GelGZJ · Traditional | 12/18/1991SE |
| K912979 | Hemawipe System, the Civilized Test, ModificationKHE · Traditional | 10/04/1991SE |
| K902738 | Electro Blue ECG Electrode-Pediatric ClothDRX · Traditional | 09/04/1990SE |
| K902719 | Spect.E.N.S. Repostion.-E Foam Pin Type TENS ElectGXY · Traditional | 07/19/1990SE |
| K900656 | Spec T.E.N.S. Prewired Repositionable TENS Elect.GXY · Traditional | 03/01/1990SE |
| K896844 | Babe-Ease Neonatal Cloth ECG ElectrodeGXY · Traditional | 02/12/1990SE |
| K896936 | L.A.S.P. Lumbar and Sacral Pad, Reposition. SnapGXY · Traditional | 01/22/1990SE |
| K894991 | Electro Blue ECG Elect. Foam, Silver/Silver Chlo.DRX · Traditional | 10/26/1989SE |
| K894462 | Care Disp. Diag. Electrodes, Silver/SilverDRX · Traditional | 10/12/1989SE |
Questions and answers
When was Lmi Medical, Electrode, Electrosurgical, Disposable Dispersive Electrode with Cord cleared by the FDA?
Lmi Medical, Electrode, Electrosurgical, Disposable Dispersive Electrode with Cord (K951328) received a 510(k) decision of Substantially Equivalent on April 25, 1995, 33 days after the submission was received.
What is the product code of K951328?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.