Electrosurg. Patient Grounding Plate
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K771352 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Electrosurg. Patient Grounding Plate is a device used in electrosurgical procedures to provide a return path for electrical current, ensuring patient safety during surgery. It is classified as a General & Plastic Surgery device under product code GEI.
This device received FDA 510(k) clearance (K771352) through the Traditional pathway on October 25, 1977, after being found substantially equivalent to a predicate device. It is manufactured by C.R. Bard, Inc. and is intended for use in general and plastic surgical settings.
Frequently asked questions
What is the Electrosurg Patient Grounding Plate used for?
The Electrosurg Patient Grounding Plate is used in electrosurgical procedures to provide a return path for electrical current, ensuring patient safety during surgery. It is specifically designed for use in general and plastic surgical settings.
How is the Electrosurg Patient Grounding Plate supplied?
The Electrosurg Patient Grounding Plate is manufactured by C.R. Bard, Inc. and is supplied as a medical device for use in surgical procedures. The device is classified under product code GEI for General & Plastic Surgery devices.
What is the regulatory status of this device?
The Electrosurg Patient Grounding Plate received FDA 510(k) clearance (K771352) through the Traditional pathway on October 25, 1977. It was found substantially equivalent to a predicate device and is manufactured by C.R. Bard, Inc.
Is the Electrosurg Patient Grounding Plate reusable or single-use?
The device data does not specify whether the Electrosurg Patient Grounding Plate is designed for single-use or reuse. This information would typically be found in the product's instructions for use or labeling materials.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K771352 FDA 510 (k) - ELECTROSURG. PATIENT GROUNDING PLATE, ELECTROSURG. PATIENT GROUNDING PLATE (K771352) — FDA 510 (k) | Innolitics, PDF K771352 - Electrosurg. Patient Grounding Plate, ELECTROSURG. PATIENT GROUNDING PLATE 510(k) K771352 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K771352 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K771352 24 fields · synced Sep 27, 2026