Modified Conductive Adhesive Electrosurgical Groun
FDA 510(k) K850129 · Consolidated Medical Equipment, Inc.
510(k) numberK850129
Submission
- Device name
- Modified Conductive Adhesive Electrosurgical Groun
- Applicant
- Consolidated Medical Equipment, Inc.
Utica, NY, US - Received
- January 14, 1985
- Decision date
- February 28, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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).
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| K854040 | I.V. DressingKMK · Traditional | 01/09/1986SE |
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| K850130 | PRN ECG ElectrodeDRX · Traditional | 04/09/1985SE |
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| K850311 | Dispos. Conductive Adhesive TENS PadGXY · Traditional | 03/05/1985SE |
| K850131 | Conductive Adhesive Post-Op Electrode-TensGXY · Traditional | 03/05/1985SE |
| K850133 | Veni-Gard Ap & TPN, Derma-Shield, Derma-Shield Jr.KGX · Traditional | 02/28/1985SE |
| K844372 | Hand Controlled Electrosurgical Pencil DisposableGEI · Traditional | 02/21/1985SE |
| K844371 | Hand Controlled Electrosurgical Pencil-ReuseableGEI · Traditional | 02/20/1985SE |
Questions and answers
When was Modified Conductive Adhesive Electrosurgical Groun cleared by the FDA?
Modified Conductive Adhesive Electrosurgical Groun (K850129) received a 510(k) decision of Substantially Equivalent on February 28, 1985, 45 days after the submission was received.
What is the product code of K850129?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.